FDA 510(k) Application Details - K022715

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K022715
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE, NJ 08876-0151 US
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Contact REY LIBROJO
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 08/15/2002
Decision Date 12/19/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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