The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Scott Needle & Scott Mick Implanter.
| Device ID | K801983 |
| 510k Number | K801983 |
| Device Name: | SCOTT NEEDLE & SCOTT MICK IMPLANTER |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-19 |
| Decision Date | 1980-10-23 |