Device Classification Name |
Photostimulator, Ac-Powered
|
510(k) Number |
K853812 |
Device Name |
PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) |
Applicant |
BIOSAN LABORATORIES, INC. |
1016 C ST. |
SAN RAFAEL,
CA
94901
|
|
Applicant Contact |
JOHN DOWNING |
Correspondent |
BIOSAN LABORATORIES, INC. |
1016 C ST. |
SAN RAFAEL,
CA
94901
|
|
Correspondent Contact |
JOHN DOWNING |
Regulation Number | 886.1630
|
Classification Product Code |
|
Date Received | 09/12/1985 |
Decision Date | 11/01/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|