FDA 510(k) Application Details - K032420

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K032420
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant ETHICON, INC.
P.O BOX 151, ROUTE 22 WEST
SOMERVILLE, NJ 08876 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 08/05/2003
Decision Date 10/22/2003
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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