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FDA 510(k) Application Details - K051415
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
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510(K) Number
K051415
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
COAPT SYSTEMS, INC.
1820 EMBARCADERO RD.
PALO ALTO, CA 94303 US
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LINDA RUEDY
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Regulation Number
878.4493
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Classification Product Code
GAM
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Date Received
06/01/2005
Decision Date
06/23/2005
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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