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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 K060828
Device Name MODIFICATION TO ENDOTINE RIBBON
Applicant
COAPT SYSTEMS, INC.
1820 EMBARCADERO RD.
PALO ALTO,  CA  94303
Applicant Contact LINDA RUEDY
Correspondent
COAPT SYSTEMS, INC.
1820 EMBARCADERO RD.
PALO ALTO,  CA  94303
Correspondent Contact LINDA RUEDY
Regulation Number878.4493
Classification Product Code
GAM  
Date Received03/27/2006
Decision Date 04/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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