KIMBERLY-CLARK INTRODUCER KITS


Device Classification Name

tube, gastro-enterostomy

510(k) Number K080253
Device Name KIMBERLY-CLARK INTRODUCER KITS
Applicant
KIMBERLY-CLARK CORP.
1400 holcomb bridge rd.
roswell, 
GA 
30076

Applicant Contact sherry saurini
Correspondent
KIMBERLY-CLARK CORP.
1400 holcomb bridge rd.
roswell, 
GA 
30076

Correspodent Contact sherry saurini
Regulation Number 876.5980
Classification Product Code
KGC  
Date Received 01/31/2008
Decision Date 02/26/2008
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No