The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Nuclear Associates Model 34-070 Brachytherapy Cal..
| Device ID | K931657 |
| 510k Number | K931657 |
| Device Name: | NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
| Contact | Robert Kobistek |
| Correspondent | Robert Kobistek VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-05 |
| Decision Date | 1993-07-27 |