Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K032734 |
Device Name |
CONVATEC FECAL MANAGEMENT SYSTEM |
Applicant |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
200 HEADQUARTERS PARK DR. |
SKILLMAN,
NJ
08558
|
|
Applicant Contact |
NANCY REGULSKI |
Correspondent |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
200 HEADQUARTERS PARK DR. |
SKILLMAN,
NJ
08558
|
|
Correspondent Contact |
NANCY REGULSKI |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/04/2003 |
Decision Date | 04/08/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|