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FDA 510(k) Application Details - K100936
Device Classification Name
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510(K) Number
K100936
Device Name
GYNECARE TVT ABBREVO CONTINENCE SYSTEM
Applicant
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE, NJ 08876-0151 US
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SUSAN LIN
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Regulation Number
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Classification Product Code
OTN
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Date Received
04/05/2010
Decision Date
07/01/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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