Device Classification Name |
protector, ostomy
|
510(k) Number |
K904233 |
Device Name |
CONVATEC ABSORBENT BANDAGE |
Applicant |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
P.O. BOX 4000 |
PRINCETON,
NJ
08540
|
|
Applicant Contact |
MARILYN DREYLING |
Correspondent |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
P.O. BOX 4000 |
PRINCETON,
NJ
08540
|
|
Correspondent Contact |
MARILYN DREYLING |
Regulation Number | 876.5900
|
Classification Product Code |
|
Date Received | 09/05/1990 |
Decision Date | 03/06/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|