| Device Classification Name |
Sunglasses (Non-Prescription Including Photosensitive)
|
| 510(k) Number |
K901047 |
| Device Name |
SUNGLASSES |
| Applicant |
| Command Marketing Corp. |
| P.O. Box 551266 |
|
Dallas,
TX
75355
|
|
| Applicant Contact |
JAMES LYNCH |
| Correspondent |
| Command Marketing Corp. |
| P.O. Box 551266 |
|
Dallas,
TX
75355
|
|
| Correspondent Contact |
JAMES LYNCH |
| Regulation Number | 886.5850 |
| Classification Product Code |
|
| Date Received | 03/06/1990 |
| Decision Date | 05/15/1990 |
| 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
|
|
|