FDA 510(k) Application Details - K102339

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene

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510(K) Number K102339
Device Name Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant CONMED LINVATEC
11311 CONCEPT BOULEVARD
LARGO, FL 33773-4908 US
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Contact JAN FLEGEAU
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Regulation Number 878.5000

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Classification Product Code GAT
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Date Received 08/18/2010
Decision Date 11/23/2010
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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