Device Classification Name |
device, fixation, ac-powered, ophthalmic
|
510(k) Number |
K781313 |
Device Name |
VISION-STIMULATOR, CAM |
Applicant |
|
Correspondent |
|
Regulation Number | 886.1290
|
Classification Product Code |
|
Date Received | 07/31/1978 |
Decision Date | 01/26/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|