The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Tbi Stand.
| Device ID | K972709 |
| 510k Number | K972709 |
| Device Name: | TBI STAND |
| Classification | Accelerator, Linear, Medical |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 1470 OUTLOOK AVE. P.O. BOX 99 Bronx, NY 10465 |
| Contact | Felix W Mick |
| Correspondent | Felix W 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 | 1997-07-21 |
| Decision Date | 1997-10-16 |
| Summary: | summary |