| 510(k) Number |
K863662 |
| Device Name |
OPHTHALMIC SURGICAL DRAPE |
| Applicant |
| Myocure, Inc. |
| 1736 Flower St. |
|
Glendale,
CA
91201
|
|
| Applicant Contact |
ALEXA C JENSEN |
| Correspondent |
| Myocure, Inc. |
| 1736 Flower St. |
|
Glendale,
CA
91201
|
|
| Correspondent Contact |
ALEXA C JENSEN |
| Date Received | 09/18/1986 |
| Decision Date | 10/20/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|