| 510(k) Number |
K871326 |
| Device Name |
DROP MATE |
| Applicant |
| Mtr Enterprises, Ltd. |
| P.O. Box 30431 |
|
Palm Beach Gardens,
FL
33410
|
|
| Applicant Contact |
JOHN G STEPANEK |
| Correspondent |
| Mtr Enterprises, Ltd. |
| P.O. Box 30431 |
|
Palm Beach Gardens,
FL
33410
|
|
| Correspondent Contact |
JOHN G STEPANEK |
| Date Received | 04/03/1987 |
| Decision Date | 04/27/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|