Device Classification Name |
Instrument, Visual Field, Laser
|
510(k) Number |
K781507 |
Device Name |
RETINOMETER |
Applicant |
COBURN OPTICAL IND., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
COBURN OPTICAL IND., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1360
|
Classification Product Code |
|
Date Received | 09/01/1978 |
Decision Date | 11/15/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|