Device Classification Name |
bandage, liquid, skin protectant
|
510(k) Number |
K861557 |
Device Name |
APLICARE SKIN PROTECTANT PREP PAD |
Applicant |
APLICARE, INC. |
7 ORCHARD PARK RD. |
MADISON,
CT
06443
|
|
Applicant Contact |
PAUL G BUCCETTI |
Correspondent |
APLICARE, INC. |
7 ORCHARD PARK RD. |
MADISON,
CT
06443
|
|
Correspondent Contact |
PAUL G BUCCETTI |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 04/25/1986 |
Decision Date | 07/11/1986 |
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
|
|
|