| Device Classification Name |
Source, Isotope, Sealed, Gold, Titanium, Platinum
|
| 510(k) Number |
K852542 |
| Device Name |
PALLADIUM SEED MODEL 100 |
| Applicant |
| Nuclear Medicine, Inc. |
| 900 Atlantic Dr. NW |
|
Atlanta,
GA
30332
|
|
| Applicant Contact |
JOHN L RUSSELL |
| Correspondent |
| Nuclear Medicine, Inc. |
| 900 Atlantic Dr. NW |
|
Atlanta,
GA
30332
|
|
| Correspondent Contact |
JOHN L RUSSELL |
| Regulation Number | 892.5730 |
| Classification Product Code |
|
| Date Received | 06/14/1985 |
| Decision Date | 01/14/1986 |
| 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
|
|
|