The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Veridose Diodes.
| Device ID | K964785 |
| 510k Number | K964785 |
| Device Name: | VERIDOSE DIODES |
| Classification | Accelerator, Linear, Medical |
| Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Solon, OH 44139 -3395 |
| Contact | Linda S Morin |
| Correspondent | Linda S Morin VICTOREEN, INC. 6000 COCHRAN RD. Solon, OH 44139 -3395 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-06-13 |
| Summary: | summary |