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FDA 510(k) Application Details - K013177
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
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510(K) Number
K013177
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
BONUTTI RESEARCH, INC.
2600 SOUTH RANEY
P.O. BOX 1367
EFFINGHAM, IL 62401 US
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PATRICK BALSMANN
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Regulation Number
878.4493
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Classification Product Code
GAM
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Date Received
09/24/2001
Decision Date
12/19/2001
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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