Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K862004 |
Device Name |
ZEISS 30 SL-L |
Applicant |
CARL ZEISS, INC. |
ONE ZEISS DR. |
THORNWOOD,
NY
10594
|
|
Applicant Contact |
MARIE PEDERSON |
Correspondent |
CARL ZEISS, INC. |
ONE ZEISS DR. |
THORNWOOD,
NY
10594
|
|
Correspondent Contact |
MARIE PEDERSON |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 05/27/1986 |
Decision Date | 06/17/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|