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FDA 510(k) Application Details - K963328
Device Classification Name
Prosthesis, Penile
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510(K) Number
K963328
Device Name
Prosthesis, Penile
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA, MN 55343 US
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KRIS TEICH
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Regulation Number
876.3630
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Classification Product Code
FAE
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More FDA Info for this Product Code
Date Received
08/23/1996
Decision Date
12/04/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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