BARD DIGNICARE STOOL MANAGEMENT SYSTEM


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K073598
Device Name BARD DIGNICARE STOOL MANAGEMENT SYSTEM
Applicant
C.R. BARD, INC.
8195 industrial blvd.
covington, 
GA 
30014

Applicant Contact michelle gudith
Correspondent
C.R. BARD, INC.
8195 industrial blvd.
covington, 
GA 
30014

Correspodent Contact michelle gudith
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 12/21/2007
Decision Date 06/13/2008
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No