| 510(k) Number |
K864656 |
| Device Name |
DZIDRA GLASS FOR USE IN OPHTHALMOLOGY |
| Applicant |
| Glen Whitten, Dds |
| 312 W. Pear St. |
|
Lakeland,
FL
33801
|
|
| Correspondent |
| Glen Whitten, Dds |
| 312 W. Pear St. |
|
Lakeland,
FL
33801
|
|
| Date Received | 11/28/1986 |
| Decision Date | 02/25/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|