| 510(k) Number |
K827126 |
| Device Name |
TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASE |
| Applicant |
| Tecnomed, Inc. |
| 2428 Hanover Ave. |
|
Richmond,
VA
23220
|
|
| Correspondent |
| Tecnomed, Inc. |
| 2428 Hanover Ave. |
|
Richmond,
VA
23220
|
|
| Date Received | 02/04/1982 |
| Decision Date | 03/05/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|