| Device Classification Name |
Frame, Spectacle
|
| 510(k) Number |
K863862 |
| Device Name |
MILITARY PRESCRIPTION FRAME |
| Applicant |
| Halo Optical Products, Inc. |
| P.O. Box 1369 |
| 9 Phair St. |
|
Gloversville,
NY
12078
|
|
| Applicant Contact |
PETER LEONARDI |
| Correspondent |
| Halo Optical Products, Inc. |
| P.O. Box 1369 |
| 9 Phair St. |
|
Gloversville,
NY
12078
|
|
| Correspondent Contact |
PETER LEONARDI |
| Regulation Number | 886.5842 |
| Classification Product Code |
|
| Date Received | 10/03/1986 |
| Decision Date | 10/20/1986 |
| 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
|
|
|