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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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More FDA Info for this Product Code
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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