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| Dockets Entered On November 27, 2006
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1999D-4114
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| Testing for Replication Competent Retrovirus in Retroviral
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| |
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| |
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| |
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| |
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| |
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| |
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| 2006F-0409
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| Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
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| 2006M-0473
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| Paragon Vision Sciences, Premarket Approval for Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses for Contact Lens Corneal Refractive Therapy, P050031
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006N-0378
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| Review of Agreements, Guidances, and Practices Specific to Assignment of Combination Products in Compliance with the Medical Device User Fee and Modernization Act of 2002
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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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| 2006P-0085
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| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 2006P-0390
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| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 1978N-0065
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| Skin Bleaching Drug Products
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| C 32
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| Form Letters
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| Vol #:
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| 16
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| C 33
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| Atlanta Center of Dermatology & Medi Spa, PC
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| Vol #:
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| 15
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| C 34
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| T. Hopkins
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| Vol #:
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| 15
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| C 35
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| Tufts New England Medical Center
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| Vol #:
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| 15
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| C 36
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| SkinCare Physicians of Chestnut Hill
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| Vol #:
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| 15
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| C 37
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| Center for Dermatology & Cosmetic Surgery
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| Vol #:
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| 15
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| EC 91
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| American Society Dermatologic Surgery (ASDS)
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| Vol #:
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| 14
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| EC 92
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| Dermatologic Care, Inc.
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| Vol #:
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| 14
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| EC 93
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| New England Medical Center
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| Vol #:
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| 14
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| EC 94
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| Dr. Mark Rubin
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| Vol #:
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| 14
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| EC 95
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| ASDS
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| Vol #:
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| 14
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| EC 96
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| Dr. Peter Hallarman
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| Vol #:
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| 14
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| EC 97
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| Dr. N. Patrick Hennessey
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| Vol #:
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| 14
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| EXT 2
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| Cosmetic, Toiletr, and Fragrance Association (CTFA)
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| Vol #:
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| 15
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| 1999D-4114
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| Testing for Replication Competent Retrovirus in Retroviral
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| GDL 3
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| Supplemental Guidance
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| Vol #:
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| 1
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 29
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| Ms. Joan Royal
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| Vol #:
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| 8
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| EXB 1
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| Exhibit G 1. Declaration of Gary W. Smagalski, D.D.S., F.A.C.D
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| Vol #:
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| 7
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| EXB 2
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| Exhibit G 2. Supplemental Declaration of Gary W. Smagalski, D.D.S, F.A.C.D.
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| Vol #:
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| 7
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| EXB 3
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| Exhibit G-3. Declaration of James Q. Swift, D.D.S.
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| Vol #:
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| 7
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| EXB 4
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| Exhibit G-4. Supplemental Declaration of James Q. Swift, D.D.S.
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| Vol #:
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| 7
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| EXB 5
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| Exhibit G-5. Supplemental Declaration of Howard A. Press
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| Vol #:
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| 7
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| EXB 6
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| R-1. Direct testimony Declaration of Robert W. Christensen
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| Vol #:
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| 10
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| EXB 7
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| R-2. Direct Testimony Declaration of James T. Curry, DDS
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| Vol #:
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| 11
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| EXB 8
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| R-3. Direct Testimony Declaration of Ricardo R. Alexander, DDS
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| Vol #:
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| 12
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| EXB 9
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| Exhibit R 4. Direct Testimony Declaration of Maureen K. Mooney
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| Vol #:
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| 13
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| EXB 10
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| R-5. Direct Testimony Declaration of Bonnie J. Ray
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| Vol #:
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| 14
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| EXB 11
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| R-6. Privilege Log for Documents 00001-4185
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| Vol #:
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| 15
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| EXB 12
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| R-7. Daniel Schultz Privilege Log for Documents 00001-4185
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| Vol #:
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| 16
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| EXB 13
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| R-8. Summary of Duplicate and Near Duplicate Documents
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| Vol #:
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| 17
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| EXB 14
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| R-9 Priveldge Log for Documents 4848-4950
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| Vol #:
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| 18
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| EXB 15
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| R-10. OC and OSB Agreement
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| Vol #:
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| 19
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| EXB 16
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| R-11. Memo of Understanding Related to Medical Device Reporting
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| Vol #:
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| 20
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| EXB 17
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| R-12. Supervisory Interdiciplinary Scientist Job Description
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| Vol #:
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| 21
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| EXB 18
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| R-13. Deborah Yodar CV
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| Vol #:
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| 22
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| EXB 19
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| R-14. Nurse Consultant Job Description
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| Vol #:
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| 23
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| EXB 20
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| R-15 Janie G. Fuller CV
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| Vol #:
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| 24
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| EXB 21
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| R-16 Director Regulatory Review Officer Job Description
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| Vol #:
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| 25
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| EXB 22
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| R-17 David Steven Shindell CV
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| Vol #:
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| 26
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| EXB 23
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| R-18 Supervisory Consumer Safety Officer Job Description
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| Vol #:
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| 27
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| EXB 24
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| R-19 Chester T. Reynolds CV
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| Vol #:
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| 28
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| EXB 25
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| R-20 Public Health Advisor Job Description
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| Vol #:
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| 29
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| EXB 26
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| R-21 Brenda Sanderson Lucas, RN CV
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| Vol #:
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| 30
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| EXB 27
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| R-22 Nurse Consultant Job Description
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| Vol #:
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| 31
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| EXB 28
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| R-23 Email (Bate stamp 0109)
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| Vol #:
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| 32
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| EXB 29
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| R-24 Email (Bate stamp 0110)
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| Vol #:
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| 33
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| EXB 30
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| R-25 Email (Bate stamp 0112)
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| Vol #:
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| 34
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| EXB 31
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| R-26 Email (Bate stamp 0113)
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| Vol #:
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| 35
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| EXB 32
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| R-27 Email (Bate stamp 0114)
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| Vol #:
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| 36
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| EXB 33
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| R-28 Email (Bate stamp 0115)
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| Vol #:
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| 37
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| EXB 34
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| R-29 Email (Bate stamp 0116)
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| Vol #:
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| 38
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| EXB 35
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| R-30 Email (Bate stamp 0118)
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| Vol #:
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| 39
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| EXB 36
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| R-31 Email (Bate stamp 0134)
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| Vol #:
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| 40
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| EXB 37
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| R-32 Email (Bate stamp 0135)
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| Vol #:
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| 41
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| EXB 38
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| R-33 Email (Bate stamp 0136)
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| Vol #:
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| 42
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| EXB 39
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| R-34 Email (Bate stamp 0137)
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| Vol #:
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| 43
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| EXB 40
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| R-35 Email (Bate stamp 0138)
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| Vol #:
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| 44
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| EXB 41
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| R-36 Email (Bate stamp 0533-34)
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| Vol #:
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| 45
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| EXB 42
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| R-37 Not Used
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| Vol #:
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| 46
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| EXB 43
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| R-38 Email (Bate stamp 1225)
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| Vol #:
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| 47
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| EXB 44
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| R-39 Email (Bate stamp 2543)
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| Vol #:
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| 48
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| EXB 45
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| R-40 Email (Bate stamp 2544)
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| Vol #:
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| 49
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| |
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| EXB 46
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| R-41 Standard Operating Procedure 202-001 Complaint Handling
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| Vol #:
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| 50
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| EXB 47
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| R-42 Standard Operating Procedure 202-002 Medical Device Reporting
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| Vol #:
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| 51
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| EXB 48
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| R-43 Form CO-107 MDR Evaluation Checklist
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| Vol #:
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| 52
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| EXB 49
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| R-44 Form CO-005 Complaint Form
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| Vol #:
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| 53
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| EXB 50
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| R-45 Form CO-060 Explant Form
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| Vol #:
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| 54
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| |
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| EXB 51
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| R-46 Label 1-084 Fossa-Eminence Instruction fro Use
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| Vol #:
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| 55
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| EXB 52
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| R-47 Label 1-085 TMJ Total Joint Instructions for Use
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| Vol #:
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| 56
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| |
|
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| LET 3
|
| FDA/CDRH/OGC
|
| Vol #:
|
| 7
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| |
|
|
| LET 4
|
| TMJ Implants Inc.
|
| Vol #:
|
| 9
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| |
|
|
| LET 5
|
| TMJ Implants Inc.
|
| Vol #:
|
| 9
|
| |
|
|
| 2005N-0403
|
| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
|
|
|
|
|
|
|
|
|
| C 5
|
| TAP Pharmaceutical Products, Inc.
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| Vol #:
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| 3
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| |
|
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| C 6
|
| Ranbaxy, Inc.
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| Vol #:
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| 3
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| |
|
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| C 7
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| Nelco Laboratories, Inc.
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| Vol #:
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| 3
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| |
|
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| EC 3
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| Ben Venue Laboratories, Inc.
|
| Vol #:
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| 3
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| |
|
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| EC 4
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| Genpharm Inc
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| Vol #:
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| 3
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| |
|
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| EC 5
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| Generic Pharmaceutical Association
|
| Vol #:
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| 3
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| |
|
|
| EC 6
|
| Taro Pharmaceuticals USA Inc.
|
| Vol #:
|
| 3
|
| |
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
| |
|
|
| C 18213
|
| K. Herceg
|
| Vol #:
|
| 198
|
| |
|
|
| 2006D-0331
|
| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
|
| |
|
|
| EC 62
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| Northfield Laboratories Inc.
|
| Vol #:
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| 3
|
|
| | | | | | | | |
| |
|
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| EC 63
|
| National Association of EMS Physicians
|
| Vol #:
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| 3
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| |
|
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| EC 64
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| Oregon Health & Science University
|
| Vol #:
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| 3
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| |
|
|
| EC 65
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| Law Student
|
| Vol #:
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| 3
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| |
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
| |
|
|
| EC 11
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| M. D. Anderson Cancer Center
|
| Vol #:
|
| 1
|
| |
|
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| 2006D-0383
|
| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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|
|
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|
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| |
|
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| C 123
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| M. Webster
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| Vol #:
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| 9
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| |
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| C 124
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| W and C YOntz
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| Vol #:
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| 9
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| |
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| C 125
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| J. Collier
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| Vol #:
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| 9
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| |
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| C 126
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| J. Kremer
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| Vol #:
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| 9
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| |
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| C 127
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| M. Brazwell
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| Vol #:
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| 9
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| |
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| C 128
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| P. Kremer
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| Vol #:
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| 9
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| |
|
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| C 129
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| Dr. T. Lisk
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| Vol #:
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| 9
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| |
|
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| C 130
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| L. Girit
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| Vol #:
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| 9
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| |
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| C 131
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| D. Laurens, M.A.
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| Vol #:
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| 9
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| |
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| C 132
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| K. Kremer
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| Vol #:
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| 9
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| |
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| EC 2077
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| Mr. William Grothus
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| Vol #:
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| 8
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| |
|
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| EC 2078
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| Mrs. Leslye Killian
|
| Vol #:
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| 8
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| |
|
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| EC 2079
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| Mr. Brion Collins
|
| Vol #:
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| 8
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| |
|
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| EC 2080
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| St. Mary's Catholic Church
|
| Vol #:
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| 8
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| |
|
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| EC 2081
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| Mr. Ryan DeCook
|
| Vol #:
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| 8
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| |
|
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| EC 2082
|
| Mrs. Samantha Negri
|
| Vol #:
|
| 8
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| |
|
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| EC 2083
|
| Mrs. Dolores Stack
|
| Vol #:
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| 8
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| |
|
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| EC 2084
|
| Mrs. Colleen Jessel
|
| Vol #:
|
| 8
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| |
|
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| EC 2085
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| Mrs. Patricia Griffin
|
| Vol #:
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| 8
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| |
|
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| EC 2086
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| Dr. Nicole Best
|
| Vol #:
|
| 8
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| |
|
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| EC 2087
|
| Ms. Elizabeth Schleck
|
| Vol #:
|
| 8
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| |
|
|
| EC 2088
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| Miss. Susan Tesorero
|
| Vol #:
|
| 8
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| |
|
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| EC 2089
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| Mr. Richard Renck
|
| Vol #:
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| 8
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| |
|
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| EC 2090
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| Mr. Andrew Bloomfield
|
| Vol #:
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| 8
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| |
|
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| EC 2091
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| Mrs. MARY SCHULTZ, BSN
|
| Vol #:
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| 8
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| |
|
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| EC 2092
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| Mr. Merton Garrison
|
| Vol #:
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| 8
|
| |
|
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| EC 2093
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| Mr. Noel Ballard
|
| Vol #:
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| 8
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| |
|
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| EC 2094
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| Mrs. Bridget McLaughlin
|
| Vol #:
|
| 8
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| |
|
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| EC 2095
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| Mrs. Mary Vilim
|
| Vol #:
|
| 8
|
|
| | | | | | | |
| |
|
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| EC 2096
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| Mr. Leonard Kuhar
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| Vol #:
|
| 8
|
| |
|
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| EC 2097
|
| Miss. Cassie Boorn
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2098
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| Mr. Al Riskowski
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2099
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| Mrs. Toni Collins
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2100
|
| Mrs. Karen Manning
|
| Vol #:
|
| 8
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| |
|
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| EC 2101
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| Mrs. Mary Landis
|
| Vol #:
|
| 8
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| |
|
|
| EC 2102
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| Mrs. Carol Peck
|
| Vol #:
|
| 8
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| |
|
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| EC 2103
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| Ms. Sieglinde McGinnis
|
| Vol #:
|
| 8
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| |
|
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| EC 2104
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| none
|
| Vol #:
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| 8
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| |
|
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| EC 2105
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| Mrs. Marianne Bianco R.D.
|
| Vol #:
|
| 8
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| |
|
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| EC 2106
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| Mr. William Mihalski
|
| Vol #:
|
| 8
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| |
|
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| EC 2107
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| Mr. Ralph Arnsparger
|
| Vol #:
|
| 8
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| |
|
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| EC 2108
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| Mrs. Stacey Freddino
|
| Vol #:
|
| 8
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| |
|
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| EC 2109
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| Ms. Gina Upperman
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| Vol #:
|
| 8
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| |
|
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| EC 2110
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| Mrs. MaryAnn Hassan
|
| Vol #:
|
| 8
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| |
|
|
| EC 2111
|
| Mrs. MaryAnn Hassan
|
| Vol #:
|
| 8
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| |
|
|
| EC 2112
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| Mrs. Margaret Sackett
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| Vol #:
|
| 8
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| |
|
|
| EC 2113
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| Ms. mary norton
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2114
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| Mrs. Tracy Sparling
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2115
|
| Mrs. Kathy Naquin
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2116
|
| Mr. David Wilton
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2117
|
| Mrs. Suzan Hudak
|
| Vol #:
|
| 8
|
| |
|
|
| EC 2118
|
| Mr. Greg Johnson
|
| Vol #:
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| 8
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| |
|
|
| EC 2119
|
| The Roman Catholic Church
|
| Vol #:
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| 8
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| |
|
|
| EC 2120
|
| Mrs. Kimberly Cole
|
| Vol #:
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| 8
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| |
|
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| EC 2121
|
| Mr. Kurtis Gunwall
|
| Vol #:
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| 8
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| |
|
|
| EC 2122
|
| Mrs. Clare Kosmalski
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| Vol #:
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| 8
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| |
|
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| EC 2123
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| Mrs. H Opiela
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| Vol #:
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| 8
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| |
|
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| EC 2124
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| Mrs. Debra Null
|
| Vol #:
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| 8
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| |
|
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| EC 2125
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| Mrs. Susan A. Crumpton
|
| Vol #:
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| 8
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| |
|
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| EC 2126
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| Miss. Mary Norick
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| Vol #:
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| 8
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| |
|
|
| EC 2127
|
| Mr. Christopher Vaness
|
| Vol #:
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| 8
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| |
|
|
| EC 2128
|
| Mrs. Flavia Vanes
|
| Vol #:
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| 8
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| |
|
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| EC 2129
|
| Dr. Hugh Masterson
|
| Vol #:
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| 8
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| |
|
|
| EC 2130
|
| Mr. Robert Jones
|
| Vol #:
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| 8
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| |
|
|
| EC 2131
|
| Mrs. michelle hanafee
|
| Vol #:
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| 8
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| |
|
|
| EC 2132
|
| Miss. Lydia Jackson
|
| Vol #:
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| 8
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|
| | | | | | | |
| |
|
|
| EC 2133
|
| Mr. Robert J. Awerkamp
|
| Vol #:
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| 8
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| |
|
|
| EC 2134
|
| Miss. Mary T. Mashburn
|
| Vol #:
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| 8
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| |
|
|
| EC 2135
|
| Mrs. Elaine Best
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| Vol #:
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| 8
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| |
|
|
| EC 2136
|
| Mrs. Barbara Patterson
|
| Vol #:
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| 8
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| |
|
|
| EC 2137
|
| Mrs. Rachael Ramirez
|
| Vol #:
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| 8
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| |
|
|
| EC 2138
|
| Mrs. Lisa Larson
|
| Vol #:
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| 8
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| |
|
|
| EC 2139
|
| Mr. Wayne Tryhuk
|
| Vol #:
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| 8
|
| |
|
|
| EC 2140
|
| Mr. Patrick Hart
|
| Vol #:
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| 8
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| |
|
|
| EC 2141
|
| Mr. Robert Kabat
|
| Vol #:
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| 8
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| |
|
|
| EC 2142
|
| Mrs. Linda Heaton
|
| Vol #:
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| 8
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| |
|
|
| EC 2143
|
| Ms. Theresa Sedlacek
|
| Vol #:
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| 8
|
| |
|
|
| EC 2144
|
| Mr. Duane Nelson
|
| Vol #:
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| 8
|
| |
|
|
| EC 2145
|
| Miss. Victoria Siebert
|
| Vol #:
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| 8
|
| |
|
|
| EC 2146
|
| Mrs. Nellita Lee
|
| Vol #:
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| 8
|
| |
|
|
| EC 2147
|
| Mrs. Sandy Bast
|
| Vol #:
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| 8
|
| |
|
|
| EC 2148
|
| Mrs. Eileen Adams
|
| Vol #:
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| 8
|
| |
|
|
| EC 2149
|
| Mr. Gary Fallon
|
| Vol #:
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| 8
|
| |
|
|
| EC 2150
|
| Mrs. Beth Eilers
|
| Vol #:
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| 8
|
| |
|
|
| EC 2151
|
| Dr. Maurice Faugot
|
| Vol #:
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| 8
|
| |
|
|
| EC 2152
|
| Mr. Albert and Geraldine Duzenack
|
| Vol #:
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| 8
|
| |
|
|
| EC 2153
|
| Mrs. victoria sampson
|
| Vol #:
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| 8
|
| |
|
|
| EC 2154
|
| Mr. Tim Schauf
|
| Vol #:
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| 8
|
| |
|
|
| EC 2155
|
| Mrs. Martha ODonnell
|
| Vol #:
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| 8
|
| |
|
|
| EC 2156
|
| Ms. stephanie duez
|
| Vol #:
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| 8
|
| |
|
|
| EC 2157
|
| Mr. Terrence Brown
|
| Vol #:
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| 8
|
| |
|
|
| EC 2158
|
| Mrs. Hazel Kliner
|
| Vol #:
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| 8
|
| |
|
|
| EC 2159
|
| Mrs. Amber Swehla
|
| Vol #:
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| 8
|
| |
|
|
| EC 2160
|
| Mrs. karen splonskowski
|
| Vol #:
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| 8
|
| |
|
|
| EC 2161
|
| Mrs. Bernadette Nielsen
|
| Vol #:
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| 8
|
| |
|
|
| EC 2162
|
| Ms. Mary Rupp
|
| Vol #:
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| 8
|
| |
|
|
| EC 2163
|
| Mrs. Melissa Przybysz
|
| Vol #:
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| 8
|
| |
|
|
| EC 2164
|
| Mrs. Penny Montijo
|
| Vol #:
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| 8
|
| |
|
|
| EC 2165
|
| Ms. cornelia linney
|
| Vol #:
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| 8
|
| |
|
|
| EC 2166
|
| St. Francis Xavier Parish, St. Joseph, MO
|
| Vol #:
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| 8
|
| |
|
|
| EC 2167
|
| Mrs. Linda Holman
|
| Vol #:
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| 8
|
| |
|
|
| EC 2168
|
| Miss. Catherine Perlock
|
| Vol #:
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| 8
|
| |
|
|
| EC 2169
|
| Mrs. Kathleen Exsted
|
| Vol #:
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| 8
|
|
| | | | | | | | |
| |
|
|
| EC 2170
|
| Mrs. Donna Slaybaugh
|
| Vol #:
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| 8
|
| |
|
|
| EC 2171
|
| Mr. Robert Renza
|
| Vol #:
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| 8
|
| |
|
|
| EC 2172
|
| Mr. Andrew Eells
|
| Vol #:
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| 8
|
| |
|
|
| EC 2173
|
| Mrs. Valerie Way
|
| Vol #:
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| 8
|
| |
|
|
| EC 2174
|
| Miss. Mary Mulvaney
|
| Vol #:
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| 8
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| |
|
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| EC 2175
|
| Mrs. Mary Jo Nelson
|
| Vol #:
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| 8
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| |
|
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| EC 2176
|
| Mrs. Kay Capetillo
|
| Vol #:
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| 8
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| |
|
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| EC 2177
|
| Mrs. Claudette Buckley
|
| Vol #:
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| 8
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| |
|
|
| EC 2178
|
| Ms. Elizabeth Jacquez
|
| Vol #:
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| 8
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| |
|
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| EC 2179
|
| Mrs. Diane Caldwell
|
| Vol #:
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| 8
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| |
|
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| EC 2180
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| Mr. Terrence Buckley
|
| Vol #:
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| 8
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| |
|
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| EC 2181
|
| Mrs. Barbara Harburg
|
| Vol #:
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| 8
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| |
|
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| EC 2182
|
| Mrs. Jennifer Ledoux
|
| Vol #:
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| 8
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| |
|
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| EC 2183
|
| Mr. robert paige
|
| Vol #:
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| 8
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| |
|
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| EC 2184
|
| Mr. Paul Harger
|
| Vol #:
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| 8
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| |
|
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| EC 2185
|
| Mrs. Noreen Frey
|
| Vol #:
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| 8
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| |
|
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| EC 2186
|
| Miss. Monica Williams
|
| Vol #:
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| 8
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| |
|
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| EC 2187
|
| Dr. R. Louise Smyth
|
| Vol #:
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| 8
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| |
|
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| EC 2188
|
| Dr. Michael Hoffman
|
| Vol #:
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| 8
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| |
|
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| EC 2189
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| Mrs. Pam Albrethsen
|
| Vol #:
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| 8
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| |
|
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| EC 2190
|
| Dr. Stanley Kenwood
|
| Vol #:
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| 8
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| |
|
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| EC 2191
|
| Mrs. Laura Huresky
|
| Vol #:
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| 8
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| |
|
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| EC 2192
|
| Mr. Paul Huresky
|
| Vol #:
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| 8
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| |
|
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| EC 2193
|
| Mr. Scott Kumer
|
| Vol #:
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| 8
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| |
|
|
| 2006F-0409
|
| Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
|
| |
|
|
| C 2
|
| Ecolab Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006M-0473
|
| Paragon Vision Sciences, Premarket Approval for Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses for Contact Lens Corneal Refractive Therapy, P050031
|
| |
|
|
| AAV 1
|
| Paragon Vision Sciences
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0352
|
| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
|
| |
|
|
| C 388
|
| K. Prior
|
| Vol #:
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| 26
|
| |
|
|
| C 389
|
| N. Gianoli
|
| Vol #:
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| 26
|
| |
|
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| C 390
|
| R. Dinkle
|
| Vol #:
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| 26
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| |
|
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| C 391
|
| P. Dodson
|
| Vol #:
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| 26
|
| |
|
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| C 392
|
| Dr. K. Chai
|
| Vol #:
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| 26
|
| |
|
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| C 393
|
| N. Gianoli
|
| Vol #:
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| 26
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|
| | | | | | | |
| |
|
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| C 394
|
| D. Watkins
|
| Vol #:
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| 26
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| |
|
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| C 395
|
| C. Griggs
|
| Vol #:
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| 26
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| |
|
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| C 396
|
| B. Yeary
|
| Vol #:
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| 26
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| |
|
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| C 397
|
| E. Krinsky
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| Vol #:
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| 26
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| |
|
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| C 398
|
| R. Murray
|
| Vol #:
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| 26
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| |
|
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| C 399
|
| M. Kolbay
|
| Vol #:
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| 26
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| |
|
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| C 400
|
| R. Talmadge
|
| Vol #:
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| 26
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| |
|
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| C 401
|
| R. McFerran, D.D.S.
|
| Vol #:
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| 26
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| |
|
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| C 402
|
| K. Fontaine
|
| Vol #:
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| 26
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| |
|
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| C 403
|
| A. Berg
|
| Vol #:
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| 26
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| |
|
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| C 404
|
| Department of the Planet Earth
|
| Vol #:
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| 26
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| |
|
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| C 405
|
| D. Frigo, J.D.
|
| Vol #:
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| 26
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| |
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| C 406
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| K. Sobota
|
| Vol #:
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| 26
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| |
|
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| C 407
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| C. Magruder
|
| Vol #:
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| 26
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| |
|
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| C 408
|
| K. Ross
|
| Vol #:
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| 26
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| |
|
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| C 409
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| Dr. B. Dawson, DC
|
| Vol #:
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| 26
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| |
|
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| C 410
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| J. Tobey
|
| Vol #:
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| 26
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| |
|
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| C 411
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| C. Otero, M.D.
|
| Vol #:
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| 26
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| |
|
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| C 412
|
| S. Dilks
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| Vol #:
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| 26
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| |
|
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| C 413
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| Dr. J. Harrington
|
| Vol #:
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| 26
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| |
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| C 414
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| A. Belcher
|
| Vol #:
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| 26
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| |
|
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| C 415
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| A. Belcher
|
| Vol #:
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| 26
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| |
|
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| C 416
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| R. Baritz, DC
|
| Vol #:
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| 26
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| |
|
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| C 417
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| K. Rusinoski
|
| Vol #:
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| 26
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| |
|
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| C 418
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| L. Turner
|
| Vol #:
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| 26
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| |
|
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| C 419
|
| C. Santangelo, MD
|
| Vol #:
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| 26
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| |
|
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| C 420
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| Dr. M. Gordon
|
| Vol #:
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| 26
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| |
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| C 421
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| J. Phelps
|
| Vol #:
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| 26
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| |
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| C 422
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| M. Jacke
|
| Vol #:
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| 26
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| |
|
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| C 423
|
| J. Megalo
|
| Vol #:
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| 26
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| |
|
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| C 424
|
| S. Jones BA, PT, DC
|
| Vol #:
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| 26
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| |
|
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| C 425
|
| R. King, DDS
|
| Vol #:
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| 26
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| |
|
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| C 426
|
| Y. Lu
|
| Vol #:
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| 26
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| |
|
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| C 427
|
| C. Skinner
|
| Vol #:
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| 26
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| |
|
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| C 428
|
| Carolyn
|
| Vol #:
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| 26
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| |
|
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| C 429
|
| Y. Gulezian
|
| Vol #:
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| 26
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| |
|
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| C 430
|
| Pure Water Committee of Western Maryland, Inc.
|
| Vol #:
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| 26
|
|
| | | | | | | | |
| |
|
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| C 431
|
| S. Patterson
|
| Vol #:
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| 26
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| |
|
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| C 432
|
| M. Dorazio
|
| Vol #:
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| 26
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| |
|
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| C 433
|
| Dr. L. Hansen
|
| Vol #:
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| 26
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| |
|
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| C 434
|
| T. Hunger
|
| Vol #:
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| 26
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| |
|
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| C 435
|
| R. Volpe
|
| Vol #:
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| 26
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| |
|
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| C 436
|
| K. Dudek
|
| Vol #:
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| 26
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| |
|
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| C 437
|
| N. Campbell
|
| Vol #:
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| 26
|
| |
|
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| C 438
|
| P. Das
|
| Vol #:
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| 26
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| |
|
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| C 439
|
| T. Moore
|
| Vol #:
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| 26
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| |
|
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| C 440
|
| U. Bengtsson
|
| Vol #:
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| 26
|
| |
|
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| C 441
|
| B. Clark
|
| Vol #:
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| 26
|
| |
|
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| C 442
|
| R. Montoya
|
| Vol #:
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| 26
|
| |
|
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| C 443
|
| S. Long
|
| Vol #:
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| 26
|
| |
|
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| C 444
|
| R. Brown
|
| Vol #:
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| 26
|
| |
|
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| C 445
|
| A. Pasche
|
| Vol #:
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| 26
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| |
|
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| C 446
|
| R. Levine
|
| Vol #:
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| 26
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| |
|
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| C 447
|
| No siganture
|
| Vol #:
|
| 26
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| |
|
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| C 448
|
| D. Ingalls
|
| Vol #:
|
| 26
|
| |
|
|
| 2006N-0378
|
| Review of Agreements, Guidances, and Practices Specific to Assignment of Combination Products in Compliance with the Medical Device User Fee and Modernization Act of 2002
|
| |
|
|
| C 1
|
| Wyeth Pharmaceuticals, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 1
|
| National Electrical Manufacturers Association
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0414
|
| Suicidality Data from Adult Antidepressant Trials
|
| |
|
|
| EC 1
|
| Citizens Commission on Human Rights of St. Louis
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| CHAADA - www.chaada.org
|
| Vol #:
|
| 1
|
| |
|
|
| EC 3
|
| Mr. Edward Pebley
|
| Vol #:
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| 1
|
| |
|
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| EC 4
|
| Ms. Patricia Robinett
|
| Vol #:
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| 1
|
| |
|
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| EC 5
|
| Mrs. Debby Paintr
|
| Vol #:
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| 1
|
| |
|
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| EC 6
|
| CHAADA
|
| Vol #:
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| 1
|
| |
|
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| EC 7
|
| Mrs. Gerry Dunn
|
| Vol #:
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| 1
|
| |
|
|
| EC 8
|
| MindFreedom
|
| Vol #:
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| 1
|
| |
|
|
| EC 9
|
| Mrs. Kimberly Osburn
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0085
|
| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
|
| |
|
|
| C 10
|
| Form Letters
|
| Vol #:
|
| 3
|
| |
|
|
| C 11
|
| Form Letters
|
| Vol #:
|
| 4
|
| |
|
|
| C 12
|
| R. Novak, MS CO
|
| Vol #:
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| 2
|
|
| | | | | | | | |
| |
|
|
| C 13
|
| D. Lima, CO, OTR/L
|
| Vol #:
|
| 2
|
| |
|
|
| C 14
|
| Children's Memorial Hospital
|
| Vol #:
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| 2
|
| |
|
|
| C 15
|
| Ortho Pro Associates, Inc.
|
| Vol #:
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| 2
|
| |
|
|
| C 16
|
| Cranial Therapies, Inc.
|
| Vol #:
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| 2
|
| |
|
|
| C 17
|
| Children Hospital Boston
|
| Vol #:
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| 2
|
| |
|
|
| EC 12
|
| american society of pediatric neurosurgery
|
| Vol #:
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| 2
|
| |
|
|
| EC 13
|
| AANS/CNS Forum on Drugs, Devices, and Biologics
|
| Vol #:
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| 2
|
| |
|
|
| EC 14
|
| Section of Pediatric Neurosurgery, AANS/CNS
|
| Vol #:
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| 2
|
| |
|
|
| EC 15
|
| Harvard Medical School/Children's Hospital, Boston
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0223
|
| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
|
|
|
|
|
|
|
|
|
| EC 715
|
| Miss. Jessica Feller
|
| Vol #:
|
| 5
|
| |
|
|
| EC 716
|
| Mr. George Burgess
|
| Vol #:
|
| 5
|
| |
|
|
| 2006P-0390
|
| Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
|
| |
|
|
| EC 15
|
| Mr. Jerry Staton
|
| Vol #:
|
| 1
|
| |
|
|
| EC 16
|
| Mr. Jerry Staton
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
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| C 21
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| Illegible
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| Vol #:
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| 6
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| EC 417
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| Miss. Randee Keiver
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| Vol #:
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| 7
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| EC 418
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| Miss. Janet Shannon
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| Vol #:
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| 7
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| EC 419
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| Mrs. Karen Tracey
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| Vol #:
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| 7
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| EC 420
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| Ms. Donna Coughlin
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| Vol #:
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| 7
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| EC 421
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| Mrs. April Beresford
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| Vol #:
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| 7
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| EC 422
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| Miss. Wynter Miceli
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| Vol #:
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| 7
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| EC 423
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| Mr. Drew Meigs
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| Vol #:
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| 7
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| EC 424
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| Ms. Amy Torgerson
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| Vol #:
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| 7
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| EC 425
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| Mr. Henry Hoecker
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| Vol #:
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| 7
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| EC 426
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| COK
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| Vol #:
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| 7
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