The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Shadow Trays.
| Device ID | K991107 |
| 510k Number | K991107 |
| Device Name: | SHADOW TRAYS |
| Classification | Accelerator, Linear, Medical |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 1470 OUTLOOK AVE. P.O. BOX 99 Bronx, NY 10465 |
| Contact | Felix Mick |
| Correspondent | Felix Mick MICK RADIO-NUCLEAR INSTRUMENTS, INC. 1470 OUTLOOK AVE. P.O. BOX 99 Bronx, NY 10465 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-06-29 |
| Summary: | summary |