| Device Classification Name |
Holder, Radiographic Cassette, Wall-Mounted
|
| 510(k) Number |
K924445 |
| Device Name |
BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY |
| Applicant |
| Control-X, Inc. |
| 2289 Westbrooke Dr. |
|
Columbus,
OH
43228
|
|
| Applicant Contact |
ZSIGMOND DOVACS |
| Correspondent |
| Control-X, Inc. |
| 2289 Westbrooke Dr. |
|
Columbus,
OH
43228
|
|
| Correspondent Contact |
ZSIGMOND DOVACS |
| Regulation Number | 892.1880 |
| Classification Product Code |
|
| Date Received | 09/01/1992 |
| Decision Date | 02/19/1993 |
| 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
|
|
|