Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K993357 |
Device Name |
IOLMASTER |
Applicant |
CARL ZEISS, INC. |
ONE ZEISS DR. |
THORNWOOD,
NY
10594
|
|
Applicant Contact |
SCOTT A MARGOLIN |
Correspondent |
CARL ZEISS, INC. |
ONE ZEISS DR. |
THORNWOOD,
NY
10594
|
|
Correspondent Contact |
SCOTT A MARGOLIN |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 10/06/1999 |
Decision Date | 03/20/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|