The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Nuclear Assoc 37-08 Ser, Raycast Hp Radio Immob Syst.
| Device ID | K935435 |
| 510k Number | K935435 |
| Device Name: | NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST |
| Classification | Accelerator, Linear, Medical |
| Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
| Contact | Christine L Jess |
| Correspondent | Christine L Jess VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-10 |
| Decision Date | 1994-07-29 |