Device Classification Name |
Keratoscope, Ac-Powered
|
510(k) Number |
K964290 |
Device Name |
EYECHEK |
Applicant |
REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC. |
3374 WALDEN AVE. |
DEPEW,
NY
14043
|
|
Applicant Contact |
FRANK J DREXELIUS |
Correspondent |
REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC. |
3374 WALDEN AVE. |
DEPEW,
NY
14043
|
|
Correspondent Contact |
FRANK J DREXELIUS |
Regulation Number | 886.1350
|
Classification Product Code |
|
Date Received | 10/28/1996 |
Decision Date | 01/09/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|