FDA 510(k) Application Details - K010909

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

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510(K) Number K010909
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant TYCO HEALTHCARE GROUP, LP
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact ROBERT ZOTT
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Regulation Number 878.5010

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Classification Product Code GAW
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Date Received 03/26/2001
Decision Date 04/09/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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