Device Classification Name |
system, x-ray, mobile
|
510(k) Number |
K782155 |
Device Name |
GENERAL EQUIPMENT COVER |
Applicant |
CONTOUR FABRICATORS, INC. |
14241 FENTON RD. |
FENTON,
MI
48430
|
|
Correspondent |
CONTOUR FABRICATORS, INC. |
14241 FENTON RD. |
FENTON,
MI
48430
|
|
Regulation Number | 892.1720
|
Classification Product Code |
|
Date Received | 12/22/1978 |
Decision Date | 01/17/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|