Device Classification Name |
Aid, Vision, Electronic, Battery-Powered
|
510(k) Number |
K862338 |
Device Name |
SENSORY 6 |
Applicant |
BRYTECH, INC. |
BOX 8823 |
OTTAWA, ONTARIO |
CANADA,
CA
K1G 3J2
|
|
Applicant Contact |
BRYENTON |
Correspondent |
BRYTECH, INC. |
BOX 8823 |
OTTAWA, ONTARIO |
CANADA,
CA
K1G 3J2
|
|
Correspondent Contact |
BRYENTON |
Regulation Number | 886.5900
|
Classification Product Code |
|
Date Received | 06/20/1986 |
Decision Date | 09/03/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|