| 510(k) Number |
K862972 |
| Device Name |
DISPOSABLE MIRROR |
| Applicant |
| Quali-Med, Inc. |
| 525 Julie Rivers Dr. |
| Suite 100 |
|
Sugar Land,
TX
77478
|
|
| Applicant Contact |
RICK FOSTER |
| Correspondent |
| Quali-Med, Inc. |
| 525 Julie Rivers Dr. |
| Suite 100 |
|
Sugar Land,
TX
77478
|
|
| Correspondent Contact |
RICK FOSTER |
| Date Received | 08/06/1986 |
| Decision Date | 09/23/1986 |
| 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
|
|
|