| 510(k) Number |
K827662 |
| Device Name |
AUTO-TECH GENERATOR |
| Applicant |
| Bennett X-Ray Corp. |
| 54 Railroad Ave. |
|
Copiague,
NY
11726
|
|
| Correspondent |
| Bennett X-Ray Corp. |
| 54 Railroad Ave. |
|
Copiague,
NY
11726
|
|
| Date Received | 06/30/1982 |
| Decision Date | 08/16/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|