FDA 510(k) Application Details - K092607

Device Classification Name

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510(K) Number K092607
Device Name AJUST ADJUSTABLE SINGLE INCISION SLING
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
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Contact JOHN C KNORPP
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Regulation Number

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Classification Product Code PAH
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Date Received 08/25/2009
Decision Date 11/20/2009
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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