| Device Classification Name |
Dressing, Wound, Drug
|
| 510(k) Number |
K897142 |
| Device Name |
MESALT STERILE DRESSING |
| Applicant |
| Scott Health Care |
| Scott Plz. Iii |
|
Philadelphia,
PA
19113
|
|
| Applicant Contact |
RICHARD A HAMER |
| Correspondent |
| Scott Health Care |
| Scott Plz. Iii |
|
Philadelphia,
PA
19113
|
|
| Correspondent Contact |
RICHARD A HAMER |
| Classification Product Code |
|
| Date Received | 12/27/1989 |
| Decision Date | 03/27/1990 |
| 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
|
|
|