FDA 510(k) Application Details - K954808

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

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510(K) Number K954808
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact JOHNATHAN GILBERT
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Regulation Number 878.5010

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Classification Product Code GAW
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Date Received 10/19/1995
Decision Date 02/27/1996
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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