Device Classification Name |
Device, Medical Examination, Ac Powered
|
510(k) Number |
K932719 |
Device Name |
RITTER MODEL 158 AND 159 EXAM LIGHTS |
Applicant |
MIDMARK CORP. |
60 VISTA DR. |
P.O. BOX 286 |
VERSAILLES,
OH
45380
|
|
Applicant Contact |
K SEIDEN |
Correspondent |
MIDMARK CORP. |
60 VISTA DR. |
P.O. BOX 286 |
VERSAILLES,
OH
45380
|
|
Correspondent Contact |
K SEIDEN |
Regulation Number | 880.6320 |
Classification Product Code |
|
Date Received | 06/04/1993 |
Decision Date | 12/02/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|