Device Classification Name |
Microscope, Surgical
|
510(k) Number |
K860811 |
Device Name |
ZEISS VOICE CONTROL SYSTEM FOR OPMI'S |
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 | 878.4700
|
Classification Product Code |
|
Date Received | 03/04/1986 |
Decision Date | 04/30/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|