COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K


Device Classification Name

endoscopic injection needle, gastroenterology-urology

510(k) Number K111495
Device Name COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
Applicant
WILSON-COOK MEDICAL INC.
4900 bethania station rd
winston-salem, 
NC 
27105

Applicant Contact marge walls-walker
Correspondent
WILSON-COOK MEDICAL INC.
4900 bethania station rd
winston-salem, 
NC 
27105

Correspodent Contact marge walls-walker
Regulation Number 876.1500
Classification Product Code
FBK  
Date Received 05/31/2011
Decision Date 07/19/2011
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