Device Classification Name |
Photostimulator, Ac-Powered
|
510(k) Number |
K831231 |
Device Name |
LED GOGGLES |
Applicant |
CADWELL LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CADWELL LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1630
|
Classification Product Code |
|
Date Received | 04/15/1983 |
Decision Date | 05/16/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|