FDA 510(k) Application Details - K980124

Device Classification Name Suture, Nonabsorbable, Silk

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510(K) Number K980124
Device Name Suture, Nonabsorbable, Silk
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact CHRISTOPHER A GRAHAM
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Regulation Number 878.5030

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Classification Product Code GAP
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Date Received 01/14/1998
Decision Date 03/27/1998
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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