FDA 510(k) Application Details - K072863

Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid

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510(K) Number K072863
Device Name Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact ALLAN P SCHWARTZ
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Regulation Number 878.4493

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Classification Product Code GAM
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Date Received 10/05/2007
Decision Date 05/23/2008
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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