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2006D-0504:
Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency
Wireless Technology in Medical Devices
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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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| NAD1
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| 12/29/2006
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| FDA
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| FDA
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| 01/03/2007
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| 137-138
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| 04/02/2007
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| txt
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| Signature:
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| KAHAN, S. LINDA
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| GDL1
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| 12/29/2006
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| 12/29/2006
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| Federal Government
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| Guidance
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| pdf
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| Signature:
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| Guidance
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| EC1
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| 02/26/2007
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| 02/20/2007
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| Device Industry
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| ABIOMED Inc.
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| htm
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| Signature:
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| Zhang, Hong
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| C1
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| 03/05/2007
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| 03/02/2007
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| Private Industry
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| Nihon Kohden America
Inc
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| pdf
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| Signature:
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| Mike Dashefsky
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| EC2
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| 04/02/2007
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| 03/12/2007
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| Device Industry
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| Mr. Edward Karst
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| htm
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| EC3
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| 04/02/2007
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| 03/15/2007
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| International Association
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| IEEE 11073 RF Wireless
SC
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| pdf
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| Signature:
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| Morrissey, Joseph
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| EC4
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| 04/02/2007
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| 03/30/2007
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| Device Industry
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| LifeSync Corporation
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| htm
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| Signature:
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| Titus, George
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| EC5
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| 04/02/2007
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| 03/30/2007
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| Device Industry
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| Olsson, Frank
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| pdf
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| Signature:
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| Phelps, Evan
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| EC6
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| 04/02/2007
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| 03/30/2007
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| Device Industry
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| Philips Medical Systems
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| pdf
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| Signature:
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| Haley, Denise
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| C2
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| 03/30/2007
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| 03/28/2007
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| Device Industry
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| Medtronic Inc
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| pdf
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| Signature:
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| Reggie Groves
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| C3
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| 04/02/2007
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| 03/30/2007
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| Device Industry
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| Boston Scientific
Corporation (BSC), Guidance Corporation
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| pdf
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| Signature:
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| Nicholas J Horvath
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| C4
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| 04/02/2007
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| 03/30/2007
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| Private Industry
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| Medical Products Group,
Abbott Laboratories
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| pdf
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| Signature:
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| April Veoukas JD
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| C5
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| 04/02/2007
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| 03/29/2007
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| Private Industry
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| IDM, a Haemonetics
Company
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| pdf
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| Signature:
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| Vicki K Moore, MS SBB, Steven
J Haw
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| C6
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| 03/29/2007
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| 03/28/2007
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| Private Industry
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| RTCA Inc
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| pdf
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| Signature:
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| David P Carson, James W Fowler
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| C7
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| 03/30/2007
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| 03/29/2007
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| Private Industry
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| Haemonetics Corporation
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| pdf
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| Signature:
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| John J Sokolowski
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| EC7
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| 04/03/2007
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| 04/02/2007
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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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| Sampogna, Thomas P.
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| EC8
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| 04/03/2007
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| 04/02/2007
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| International Organization
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| Wi-Fi Alliance
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| pdf
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| Signature:
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| Roman, John
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| EC9
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| 04/03/2007
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| 04/02/2007
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| International Organization
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| IEEE 802.18 Radio
Regulatory TAG
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| htm
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| Signature:
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| Lynch, Michael
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| EC10
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| 04/03/2007
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| 04/02/2007
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| Device Industry
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| LifeScan, Inc.
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| pdf
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| Signature:
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| Hughes, John
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| EC11
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| 04/03/2007
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| 04/02/2007
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| Device Industry
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| Draeger Medical
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| pdf
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| Signature:
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| Levy, Andrew
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| EC12
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| 04/03/2007
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| 04/02/2007
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| Device Industry
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| BIOTRONIK, Inc.
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| htm
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| Signature:
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| Brumbaugh, Jon
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| EC13
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| 04/03/2007
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| 04/02/2007
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| Other Organization
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| Kaiser Permanente
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| htm
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| Signature:
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| Barrueta, Anthony
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| EC14
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| 04/03/2007
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| 04/02/2007
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| Health Care Association
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| Massachusetts Health
Data Consortium, Inc.
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| pdf
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| Signature:
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| Hampton, Rickey
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| EMC1
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| 04/04/2007
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| 04/04/2007
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| International Industry
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| Siemens Medical Solutions
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| pdf
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| Signature:
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| Robert Sitzmann
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| EMC2
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| 04/04/2007
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| 04/04/2007
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| Private Industry
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| Massachussetts Health
Data Consortium
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| pdf
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| Signature:
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| Craig D. Schneider, Ph. D.
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| C8
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| 04/05/2007
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| 04/02/2007
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| Private Industry
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| GE Healthcare
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| pdf
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| Signature:
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| Gerald Buss
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Top
| Up
Page last updated:
April 18, 2007
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