| 510(k) Number |
K850881 |
| Device Name |
ALBA DRY BURN PAD |
| Applicant |
| Alba Health Care |
| Post Office Box 100 |
|
Valdese,
NC
28690
|
|
| Applicant Contact |
VICTOR H GARROUQ |
| Correspondent |
| Alba Health Care |
| Post Office Box 100 |
|
Valdese,
NC
28690
|
|
| Correspondent Contact |
VICTOR H GARROUQ |
| Date Received | 03/04/1985 |
| Decision Date | 04/17/1985 |
| 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
|
|
|