Device Classification Name |
Processor, Radiographic-Film, Automatic
|
510(k) Number |
K890486 |
Device Name |
MXR-14 FILM PROCESSOR |
Applicant |
CORDELL, INC. |
SIX CENTENNIAL DR. |
PEABODY,
MA
01960
|
|
Applicant Contact |
RICHARD C REEDY |
Correspondent |
CORDELL, INC. |
SIX CENTENNIAL DR. |
PEABODY,
MA
01960
|
|
Correspondent Contact |
RICHARD C REEDY |
Regulation Number | 892.1900 |
Classification Product Code |
|
Date Received | 01/31/1989 |
Decision Date | 04/03/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|