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2006N-0292:
Unique Device Identification
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| TS4
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| 11/02/2006
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| 11/02/2006
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| Federal Government
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| DoD
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| htm
pdf
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| Development, Maintenance
and Use of a Product Data Utility (PDU) for UDI Related Information
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| Signature:
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| Kathleen Garvin
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| TS5
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| 11/02/2006
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| 11/02/2006
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| Private Industry
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| Health Technology
Evaluation and Safety
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| htm
pdf
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| Panel Discussion on
Use of Automatic Identification Technologies
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| Signature:
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| James P Keller
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| TS6
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| 11/02/2006
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| 11/02/2006
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| Individual Consumer
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| M Piper
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| htm
pdf
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| Department of Defense
Item Unique Identification Program
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| TS7
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| 11/02/2006
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| 11/02/2006
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| Academia
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| Villanova School of
Business
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| htm
pdf
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| An Industry and Standards
perspective on FDA's Unique Device Identifier NPR
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| Signature:
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| Elliot B Sloane PhD
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| TS8
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| 11/02/2006
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| 11/02/2006
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| Private Industry
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| Novation
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| pdf
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| Novation - In Support
of UDI
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| Signature:
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| Cathy Denning RN MSN
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| TS9
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| 11/02/2006
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| 11/02/2006
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| Association
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| National Electrical
Manufacturers Association (NEMA)
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| htm
pdf
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| FDA Unique Identification
System (UDI) for Medical Devices
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| Signature:
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| Richard Eaton
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| TS10
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| 11/02/2006
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| 11/02/2006
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| Private Industry
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| Fast Track Technologies
Ltd
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| pdf
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| Rationale for a Unique
Device Identifier
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| Signature:
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| Brad Sokol
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| TS11
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| 11/02/2006
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| 11/02/2006
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| Association
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| Dental Trade Alliance
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| pdf
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| Signature:
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| Gary Price
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| TS12
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| 11/02/2006
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| 11/02/2006
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| Association
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| NFD, HCA
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| pdf
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| Medical Device Marking
with RFID Barcode
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| Signature:
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| In K Mun PhD
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| TS13
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| 11/02/2006
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| 11/02/2006
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| Private Industry
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| Siemens
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| pdf
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| FDA Public Meeting
on Unique Device Identification
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| Signature:
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| Jeff Schaengold
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| EC31
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| 11/03/2006
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| 11/02/2006
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| Health Professional
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| Dr. Dell Mather
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| htm
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| C1
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| 11/06/2006
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| 11/03/2006
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| Health Care Association
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| Heath Industry Business
Communications Council (HIBCC)
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| pdf
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| Signature:
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| Sara Polansky
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| C2
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| 11/07/2006
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| 11/06/2006
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| Health Care Association
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| American Hospital
Association (AHA) and the Association for Healthcare Resource
& Materials Manageme
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| pdf
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| Signature:
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| Rick Pollack and Deborah Sprindzuna
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| C3
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| 11/08/2006
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| 11/07/2006
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| Device Industry
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| Hand Held Products,
Inc. (Hand Held)
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| pdf
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| Signature:
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| George S. Smith, II
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| C4
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| 11/08/2006
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| 11/03/2006
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| Drug Industry
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| Cardinal Health
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| pdf
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| Signature:
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| David G. Perkins, J.D.
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| EC32
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| 11/09/2006
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| 11/03/2006
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| Device Industry
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| ASPECT MEDICAL SYSTEMS,
INC.
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| pdf
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| Signature:
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| VERMA, VIKRAM
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| EC33
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| 11/09/2006
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| 11/03/2006
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| Health Care Association
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| HIBCC
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| pdf
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| Signature:
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| Hankin, Robert
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| EC34
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| 11/09/2006
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| 11/03/2006
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| Health Professional
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| Texas Health Resources
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| pdf
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| Signature:
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| Hawthorne, Douglas
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| EC35
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| 11/09/2006
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| 11/04/2006
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| Individual Consumer
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| The Neuenschwander
Company
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| pdf
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| Signature:
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| Neuenschwander, Mark
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| EC36
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| 11/09/2006
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| 11/07/2006
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| Health Professional
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| Avera St. Luke's
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| htm
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| Signature:
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| Larson, Christine
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| EC37
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| 11/09/2006
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| 11/07/2006
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| Association
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| American Association
of People with Disabilities
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| pdf
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| Signature:
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| Imparato, Andrew
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| EC38
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| 11/09/2006
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| 11/07/2006
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| International Organization
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| GS1 US
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| pdf
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| Signature:
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| Roberts, John
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| EC39
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| 11/09/2006
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| 11/08/2006
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| Device Association
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| Medical Device Manufacturers
Association
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| pdf
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| Signature:
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| Leahey, Mark
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| EC40
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| 11/09/2006
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| 11/08/2006
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| Device Industry
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| 3M
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| htm
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| Signature:
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| Sardeson, Scott
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| EC41
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| 11/09/2006
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| 11/08/2006
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| Device Industry
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| 3M
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| htm
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| Signature:
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| Sardeson, Scott
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| EC42
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| 11/09/2006
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| 11/08/2006
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| Device Industry
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| 3M
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| htm
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| Signature:
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| Sardeson, Scott
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| EC43
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| 11/09/2006
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| 11/08/2006
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| Health Care Association
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| ASTRO
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| pdf
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| Signature:
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| Thevenot, Laura
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| EC44
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| 11/09/2006
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| 11/08/2006
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| Device Industry
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| Humagen Fertility
Diagnostics, Inc.
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| htm
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| Signature:
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| Showalter, Cynthia
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| EC45
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| 11/09/2006
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| 11/08/2006
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| Federal Government
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| Dep. Asst. Sec. of
Def. (FHP&R)
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| pdf
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| Signature:
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| Embrey, Ellen
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| EC46
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| 11/09/2006
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| 11/08/2006
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| Device Industry
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| CIBA Vision Corporation
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| htm
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| Signature:
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| Mens, Andrew
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| EC47
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| 11/09/2006
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| 11/08/2006
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| Device Industry
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| Hospira, Inc.
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| pdf
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| Signature:
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| Silkaitis, Ray
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| EC48
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| 11/09/2006
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| 11/08/2006
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| Health Care Association
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| America's Health Insurance
Plans
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| pdf
Attachment
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| Signature:
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| Wilder, Thomas
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| EC49
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| 11/09/2006
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| 11/08/2006
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| Health Care Association
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| Novation
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| htm
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| Signature:
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| Denning, Cathy
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| EC50
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| 11/09/2006
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| 11/08/2006
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| Health Care Association
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| Novation, LLC
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| htm
Attachment
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| Signature:
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| Denning, Cathy
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| EC51
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| 11/09/2006
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| 11/08/2006
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| Device Industry
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| Thermark Holdings,
Inc.
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| pdf
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| Signature:
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| Assaraf, Joel
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| EC52
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| 11/09/2006
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| 11/08/2006
|
| Individual Consumer
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| InfoGlyph Inc.
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| htm
Attachment
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| Signature:
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| Maybaum, William
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| Next | Most Recent Page last updated:
January 8, 2007
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