| Device Classification Name |
Frame, Spectacle
|
| 510(k) Number |
K872062 |
| Device Name |
EYEDENTITY EYEWEAR |
| Applicant |
| Vitech Research C/O Johnsen, Manfredi & Thorpe |
| Eleventh Floor |
| 10900 Wilshire Blvd. |
|
Los Angeles,
CA
90024
|
|
| Applicant Contact |
ROBERT B HUBBELL |
| Correspondent |
| Vitech Research C/O Johnsen, Manfredi & Thorpe |
| Eleventh Floor |
| 10900 Wilshire Blvd. |
|
Los Angeles,
CA
90024
|
|
| Correspondent Contact |
ROBERT B HUBBELL |
| Regulation Number | 886.5842 |
| Classification Product Code |
|
| Date Received | 05/28/1987 |
| Decision Date | 06/12/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|