| Device Classification Name |
Sunglasses (Non-Prescription Including Photosensitive)
|
| 510(k) Number |
K873405 |
| Device Name |
SUPERVISOR SUN GOGGLES(TM) |
| Applicant |
| Eye Communications, Inc. |
| 1209 S. Shamrock |
|
Monrovia,
CA
91016
|
|
| Applicant Contact |
BILL SARDI |
| Correspondent |
| Eye Communications, Inc. |
| 1209 S. Shamrock |
|
Monrovia,
CA
91016
|
|
| Correspondent Contact |
BILL SARDI |
| Regulation Number | 886.5850 |
| Classification Product Code |
|
| Date Received | 08/25/1987 |
| Decision Date | 01/11/1988 |
| 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
|
|
|