Device Classification Name |
Camera, Multi Format, Radiological
|
510(k) Number |
K950359 |
Device Name |
KONICA LASER IMAGER LI-21 |
Applicant |
STORCH, AMINI, & MUNVES, P.C. |
THE CHRYSLER BUILDING |
405 LEXINGTON AVENUE |
NEW YORK,
NY
10174
|
|
Applicant Contact |
RUSSELL D MUNVES |
Correspondent |
STORCH, AMINI, & MUNVES, P.C. |
THE CHRYSLER BUILDING |
405 LEXINGTON AVENUE |
NEW YORK,
NY
10174
|
|
Correspondent Contact |
RUSSELL D MUNVES |
Regulation Number | 892.2040
|
Classification Product Code |
|
Date Received | 01/27/1995 |
Decision Date | 09/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|