The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Victoreen Model 530.
| Device ID | K931927 |
| 510k Number | K931927 |
| Device Name: | VICTOREEN MODEL 530 |
| Classification | Accelerator, Linear, Medical |
| Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
| Contact | Robert J Kobistek |
| Correspondent | Robert J Kobistek 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 | 1993-04-16 |
| Decision Date | 1993-11-15 |