| Device Classification Name |
Tube Mount, X-Ray, Diagnostic
|
| 510(k) Number |
K873283 |
| Device Name |
MODEL C2-5000 OVERHEAD TUBE SUPPORT |
| Applicant |
| Transworld X-Ray Corp. |
| P O Box 240766 |
|
Charlotte,
NC
28224
|
|
| Applicant Contact |
PRINCEHORN |
| Correspondent |
| Transworld X-Ray Corp. |
| P O Box 240766 |
|
Charlotte,
NC
28224
|
|
| Correspondent Contact |
PRINCEHORN |
| Regulation Number | 892.1770 |
| Classification Product Code |
|
| Date Received | 08/17/1987 |
| Decision Date | 09/10/1987 |
| 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
|
|
|