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2005P-0121:
Non-invasive Bone Growth Stimulator be reclasssified from Class
III to Class II in accordance with Secton 513(e) of the Food and
Drug and Cosmetic Act(FDCA), 21 CFR 860.123 and 21 CFR 860.130
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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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| CCP1
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| 03/29/2005
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| 02/09/2005
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| Device Industry
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| RS Medical
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| Table
of Contents
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| Signature:
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| William Carroll
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| ACK1
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| 03/30/2005
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| 03/30/2005
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| Federal Government
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| HFA-305 to RS Medical
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| C1
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| 07/01/2005
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| 06/28/2005
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| Academial
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| Upstate Medical University
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| pdf
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| Signature:
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| Hansen A. Yuan, M.D.
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| C2
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| 07/11/2005
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| 07/08/2005
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| Drug Industry
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| EBI A Biomet Company
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| pdf
Att 1,
Att 2
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| Links updated 4/27/07
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| Signature:
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| Barry E. Sands
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| TS1
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| 07/21/2005
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| 07/21/2005
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| Private Industry
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| King & Spalding
LLP
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| pdf
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| Signature:
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| Edward M Basile
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| C3
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| 07/27/2005
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| 07/26/2005
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| Academia
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| Robert Wood Johnson
Medical School
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| pdf
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| Signature:
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| Nicola C. Partridge, PhD
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| LET1
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| 08/03/2005
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| 08/03/2005
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| Federal Government
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| HFZ-1 to RS Medical
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| pdf
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| Signature:
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| Linda S Kahan
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| LET2
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| 08/04/2005
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| 08/04/2005
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| Device Industry
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| RS Medical
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| pdf
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| Signature:
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| William Carroll
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| LET3
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| 08/18/2005
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| 08/18/2005
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| Federal Government
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| HFZ-400 to RS Medical
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| pdf
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| Signature:
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| Donna-Bea Tillman, PhD
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| C4
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| 08/17/2005
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| 08/17/2005
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| Private Industry
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| BGS Reclassification
Opposition Group (BGS Group)
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| Table
of Contents
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| Signature:
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| Edward M. Basile
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| C5
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| 08/18/2005
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| 08/12/2005
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| Private Industry
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| Texas Back Institute
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| pdf
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| Signature:
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| Barton L. Sachs, MD, MBA
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| C6
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| 10/11/2005
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| 10/11/2005
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| Private Industry
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| DJ Ortho
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| pdf,
Tab A, Tab
B
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| Signature:
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| Donald M Roberts
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| C7
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| 10/11/2005
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| 10/11/2005
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| Private Industry
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| Core Medical Center
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| pdf
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| Signature:
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| Raymond J Linovitz MD FACS
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| SUP1
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| 10/13/2005
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| 10/13/2005
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| Private Industry
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| DJ Ortho
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| pdf
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| Supplement material
to C6
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| Signature:
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| DJ Ortho
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| C8
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| 10/12/2005
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| 10/12/2005
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| Private Industry
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| Foundren Orthopedic
Group, LLC
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| pdf
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| Signature:
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| John O. Bishop, MD
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| AMD1
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| 12/06/2005
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| 12/06/2005
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| Device Industry
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| RS Medical
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| Table
of Contents
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| Signature:
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| William Carroll
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| C9
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| 02/10/2006
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| 02/10/2006
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| Private Industry
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| BGS Reclassification
Opposition Group (BGS Group)
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| pdf
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| Signature:
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| Edward M. Basile
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| C10
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| 02/17/2006
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| 02/17/2006
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| Private Industry
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| EBI., L.P.
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| pdf
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| Signature:
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| Jonathan S. Kahan
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| C11
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| 03/07/2006
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| 03/07/2006
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| Private Industry
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| BGS Reclassification
Opposition Group (BGS Group)
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| pdf
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| Signature:
| Edward M. Basile
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| TS2
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| 04/10/2006
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| 04/10/2006
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| Private Industry
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| King & Spalding
LLP
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| pdf
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| Opposition to the
Down-Classification of External Bone Growth Stimulators
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|
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| Signature:
| Edward M. Basile
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| RC1
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| 05/02/2006
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| 05/01/2006
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| Device Industry
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| RS Medical
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| pdf
Attachment
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|
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| Signature:
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| Robert L. Sheridan
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| SUP2
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| 05/18/2006
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| 05/18/2006
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| Device Industry
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| RS Medical
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| pdf
Attachments
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|
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| Signature:
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| Natalia Owen, M.S., CCRA
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|
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| LET4
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| 05/19/2006
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| 05/19/2006
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| Device Industry
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| BGS Reclassification
Opposition Group (BGS Group)
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| pdf
Attachment
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|
|
|
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| Signature:
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| Edward M. Basile
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| C12
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| 05/19/2006
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| 05/19/2006
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| Academia
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| Columbia University
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| pdf
Attachment
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|
|
|
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| Signature:
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| Arthur A. Pilla, PhD
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|
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| N1
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| 01/16/2007
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| FDA
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| FDA
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| 01/17/2007
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| 1951-1954
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| 04/17/2007
|
| txt
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| Comment due on 04/17/2007
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|
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| Signature:
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| KAHAN, S. LINDA
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| BKG1
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| 01/12/2007
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| 03/30/2005
|
| Federal Government
|
| Background Material
|
|
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| 2 Total Volumes
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|
|
|
|
| Signature:
|
| Background Material
|
|
|
|
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| C13
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| 03/09/2007
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| 03/07/2007
|
| Private Industry
|
| Pennsylvania Spine
Institute
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| William J Beutler MD
|
|
|
|
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| C14
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| 03/27/2007
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| 03/18/2007
|
| Private Industry
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| The Cleveland Clinic
Foundation
|
|
|
|
|
|
|
| pdf
Attachments
|
|
|
|
|
| Signature:
|
| Ronald J Midura PhD
|
|
|
|
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| WDL1
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| 04/05/2007
|
| 04/02/2007
|
| Device Industry
|
| RS Medical
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| William Carroll
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|
|
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| C15
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| 04/10/2007
|
| 04/05/2007
|
| Private Industry
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| Shapiro Clinical Center
|
|
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|
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| pdf
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|
|
|
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| Signature:
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| Paul A Glazer MD
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|
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| C16
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| 04/16/2007
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| 04/11/2007
|
| Private Industry
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| Center for Orthopaedics
|
|
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|
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|
|
| pdf
|
|
|
|
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| Signature:
|
| Neil Kahanovitz, M. D.
|
|
|
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| C17
|
| 04/17/2007
|
| 04/12/2007
|
| Private Industry
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| Healthonics-The Biophysics
Health Company
|
|
|
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|
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| pdf
|
|
|
|
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| Signature:
|
| Jim Naftel
| |
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| C18
|
| 04/17/2007
|
| 04/16/2007
|
| Private Industry
|
| Smith & Nephew
|
|
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| pdf
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|
|
|
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| Signature:
|
| Barbara Rohan
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| C19
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| 04/17/2007
|
| 04/17/2007
|
| Private Industry
|
| Bone Growth Stimulator
(BGS)
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|
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|
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| pdf
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|
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|
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| Signature:
|
| Edward M. Basile
| |
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Top
| Up
Page last updated:
April 27, 2007
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