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FDA 510(k) Application Details - K052401
Device Classification Name
More FDA Info for this Device
510(K) Number
K052401
Device Name
GYNECARE TVT SECUR SYSTEM
Applicant
ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE, NJ 08876 US
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Contact
PATRICIA M HOJNOSKI
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PAH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/01/2005
Decision Date
11/28/2005
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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