Device Classification Name |
instrument, measuring, lens, ac-powered
|
510(k) Number |
K944022 |
Device Name |
LENSCHEK |
Applicant |
LEICA, INC. |
P.O. BOX 123 |
BUFFALO,
NY
14240 -0123
|
|
Applicant Contact |
FRANK J DREXELIUS |
Correspondent |
LEICA, INC. |
P.O. BOX 123 |
BUFFALO,
NY
14240 -0123
|
|
Correspondent Contact |
FRANK J DREXELIUS |
Regulation Number | 886.1425
|
Classification Product Code |
|
Date Received | 08/17/1994 |
Decision Date | 11/17/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|