ENDOTINE RIBBON


Device Classification Name

suture, absorbable, synthetic, polyglycolic acid

510(k) Number K050611
Device Name 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

Correspodent Contact linda ruedy
Regulation Number 878.4493
Classification Product Code
GAM  
Date Received 03/09/2005
Decision Date 04/06/2005
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