FDA 510(k) Application Details - K982646

Device Classification Name Suture, Absorbable, Natural

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510(K) Number K982646
Device Name Suture, Absorbable, Natural
Applicant MYCO MEDICAL SUPPLIES, INC.
101 ROSE VALLEY WOODS DR.
CARY, NC 27513 US
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Contact SANJIV KUMAR
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Regulation Number 878.4830

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Classification Product Code GAL
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Date Received 07/29/1998
Decision Date 06/02/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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