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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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More FDA Info for this Product Code
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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