The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Modular X-ray Barriers.
| Device ID | K850814 |
| 510k Number | K850814 |
| Device Name: | MODULAR X-RAY BARRIERS |
| Classification | Screen, Leaded, Operator Radiation Protector |
| Applicant | VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
| Contact | Glasser |
| Correspondent | Glasser VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
| Product Code | EAK |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-28 |
| Decision Date | 1985-04-10 |