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FDA 510(k) Application Details - K963265
Device Classification Name
Device, Incontinence, Urosheath Type, Sterile
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510(K) Number
K963265
Device Name
Device, Incontinence, Urosheath Type, Sterile
Applicant
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
100 HEADQUARTERS PARK DR.
SKILLMAN, NJ 08558 US
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SUSIE MERCHANT
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Regulation Number
876.5250
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Classification Product Code
EXJ
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Date Received
08/20/1996
Decision Date
10/25/1996
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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