COMFORTGLIDE INTERMITENT CATHETER


Device Classification Name

catheter, straight

510(k) Number K112137
Device Name COMFORTGLIDE INTERMITENT CATHETER
Applicant
C.R. BARD, INC.
8195 industrial blvd.
covington, 
GA 
30014

Applicant Contact stacci cronk
Regulation Number 876.5130
Classification Product Code
EZD  
Date Received 07/26/2011
Decision Date 08/26/2011
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No