DISPOSABLE HEMOSTASIS CHIP


Device Classification Name

hemostatic metal clip for the gi tract

510(k) Number K121505
Device Name DISPOSABLE HEMOSTASIS CHIP
Applicant
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
4900 bethania station road
winston-salem, 
NC 
27105

Applicant Contact scottie fariole
Correspondent
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
4900 bethania station road
winston-salem, 
NC 
27105

Correspodent Contact scottie fariole
Regulation Number 876.4400
Classification Product Code
PKL  
Date Received 05/21/2012
Decision Date 08/31/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No