Device Classification Name |
Collector, Ostomy
|
510(k) Number |
K851840 |
Device Name |
STOMAHESIVE SKIN BARRIER STERILE |
Applicant |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
P.O. BOX 4000 |
PRINCETON,
NJ
08540
|
|
Applicant Contact |
PETER C KALLOS |
Correspondent |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
P.O. BOX 4000 |
PRINCETON,
NJ
08540
|
|
Correspondent Contact |
PETER C KALLOS |
Regulation Number | 876.5900
|
Classification Product Code |
|
Date Received | 04/26/1985 |
Decision Date | 06/24/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|