| 510(k) Number |
K828249 |
| Device Name |
MODEL 4045 RADIONUCLIDE CALIBRATOR |
| Applicant |
| Radcal Corp. |
| 426 W Duarte Rd. |
|
Monrovia,
CA
91016
|
|
| Correspondent |
| Radcal Corp. |
| 426 W Duarte Rd. |
|
Monrovia,
CA
91016
|
|
| Date Received | 09/10/1982 |
| Decision Date | 09/29/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|