DIAMOND-FLEX(R) GRASPERS


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K110257
Device Name DIAMOND-FLEX(R) GRASPERS
Applicant
CAREFUSION 2200, INC.
1500 waukegan road
mcgaw park, 
IL 
60085

Applicant Contact jane weber
Correspondent
CAREFUSION 2200, INC.
1500 waukegan road
mcgaw park, 
IL 
60085

Correspodent Contact jane weber
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 01/28/2011
Decision Date 05/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No