| 510(k) Number |
K850246 |
| Device Name |
MASTER KIT A |
| Applicant |
| Pro-Lab, Inc. |
| Post Office Box 11276 |
|
Birmingham,
AL
35201
|
|
| Applicant Contact |
DAN MCDONALD |
| Correspondent |
| Pro-Lab, Inc. |
| Post Office Box 11276 |
|
Birmingham,
AL
35201
|
|
| Correspondent Contact |
DAN MCDONALD |
| Date Received | 01/22/1985 |
| Decision Date | 04/09/1985 |
| 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
|
|
|