RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612


Device Classification Name

hemostatic metal clip for the gi tract

510(k) Number K122660
Device Name RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
Applicant
Boston Scientific Corporation
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact thomas hirte
Correspondent
Boston Scientific Corporation
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact thomas hirte
Regulation Number 876.4400
Classification Product Code
PKL  
Date Received 08/31/2012
Decision Date 12/03/2012
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