| 510(k) Number |
K821797 |
| Device Name |
ACTISORB* ACTIVATED CHARCOAL CLOTH DRSG. |
| Applicant |
| Johnson & Johnson Professionals, Inc. |
| 325 Paramount Dr. |
|
Raynham,
MA
02767
|
|
| Correspondent |
| Johnson & Johnson Professionals, Inc. |
| 325 Paramount Dr. |
|
Raynham,
MA
02767
|
|
| Date Received | 06/18/1982 |
| Decision Date | 09/14/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|