FDA 510(k) Application Details - K961997

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K961997
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact JONATHAN GILBERT
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 05/22/1996
Decision Date 07/16/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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