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
|
|
Correspondent Contact |
MICHELLE GUDITH |
Regulation Number | 876.5980
|
Classification Product Code |
|
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
|
|
|