FDA 510(k) Application Details - K061700

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

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510(K) Number K061700
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant NEOTRACT, INC.
4472 WILLOW ROAD
SUITE 100
PLEASANTON, CA 94588 US
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Contact KEVIN MACDONALD
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Regulation Number 878.5010

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Classification Product Code GAW
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Date Received 06/16/2006
Decision Date 10/26/2006
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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