Device Classification Name |
bandage, liquid
|
510(k) Number |
K925004 |
Device Name |
ALLKARE BARRIER WIPE |
Applicant |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
P.O. BOX 4000 |
PRINCETON,
NJ
08540
|
|
Applicant Contact |
STEVEN R PELTIER |
Correspondent |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
P.O. BOX 4000 |
PRINCETON,
NJ
08540
|
|
Correspondent Contact |
STEVEN R PELTIER |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 10/02/1992 |
Decision Date | 01/12/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|