The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Gammamed 12i.
| Device ID | K891131 |
| 510k Number | K891131 |
| Device Name: | GAMMAMED 12I |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. P.O. BOX 99 Bronx, NY 10465 |
| Contact | Felix W Mick |
| Correspondent | Felix W Mick MICK RADIO-NUCLEAR INSTRUMENTS, INC. P.O. BOX 99 Bronx, NY 10465 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-03 |
| Decision Date | 1989-08-07 |