| Device Classification Name |
Table, Radiographic, Stationary Top
|
| 510(k) Number |
K904187 |
| Device Name |
ECONOMY C-ARM TABLE, MODEL # 056-005 |
| Applicant |
| Atomic Products Corp. |
| P.O. Drawer R |
|
Shirley,
NY
11967
|
|
| Applicant Contact |
CLYDE SCHLEIN |
| Correspondent |
| Atomic Products Corp. |
| P.O. Drawer R |
|
Shirley,
NY
11967
|
|
| Correspondent Contact |
CLYDE SCHLEIN |
| Regulation Number | 892.1980 |
| Classification Product Code |
|
| Date Received | 09/12/1990 |
| Decision Date | 11/29/1990 |
| 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
|
|
|