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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K032698
Device Name COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE
Applicant
Coapt Systems, Inc.
1820 Embarcadero Rd.
Palo Alto,  CA  94303
Applicant Contact LORI DONDIEGO
Correspondent
Coapt Systems, Inc.
1820 Embarcadero Rd.
Palo Alto,  CA  94303
Correspondent Contact LORI DONDIEGO
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
HWC  
Date Received09/02/2003
Decision Date 10/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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