FDA 510(k) Application Details - K993998

Device Classification Name Suture, Nonabsorbable, Synthetic, Polyamide

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510(K) Number K993998
Device Name Suture, Nonabsorbable, Synthetic, Polyamide
Applicant TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC.
157 WINDDANCE DR.
CHICAGO, IL 60046 US
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Contact MAIN M GHAZAL
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Regulation Number 878.5020

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Classification Product Code GAR
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Date Received 11/24/1999
Decision Date 02/04/2000
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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