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FDA 510(k) Application Details - K132054
Device Classification Name
More FDA Info for this Device
510(K) Number
K132054
Device Name
GYNECARE TVT EXACT CONTINENCE SYSTEM
Applicant
ETHICON, INC.
P.O. BOX 151
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
07/03/2013
Decision Date
08/23/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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