FDA 510(k) Application Details - K014021

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K014021
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING, PA 19606 US
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Contact ELIZABETH LAZARO
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 12/06/2001
Decision Date 01/28/2002
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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