Device Classification Name |
tray, surgical, needle
|
510(k) Number |
K883578 |
Device Name |
S 21 INSTRUMENT STAND |
Applicant |
CARL ZEISS, INC. |
ONE ZEISS DR. |
THORNWOOD,
NY
10594
|
|
Applicant Contact |
VAN CADER |
Correspondent |
CARL ZEISS, INC. |
ONE ZEISS DR. |
THORNWOOD,
NY
10594
|
|
Correspondent Contact |
VAN CADER |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 08/22/1988 |
Decision Date | 09/13/1988 |
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
|
|
|