FDA 510(k) Application Details - K073493

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K073493
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant VYGON CORP.
2495 GENERAL ARMISTEAD AVE
NORRISTOWN, PA 19403 US
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Contact COURTNEY SMITH
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 12/12/2007
Decision Date 05/06/2008
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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