The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for 36-101 Xds111 Xenon Delivery/trap System.
| Device ID | K860504 |
| 510k Number | K860504 |
| Device Name: | 36-101 XDS111 XENON DELIVERY/TRAP SYSTEM |
| Classification | Assembly, Tube Housing, X-ray, Diagnostic |
| 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 | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-11 |
| Decision Date | 1986-04-04 |