The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Gamma Med Ii.
| Device ID | K781274 |
| 510k Number | K781274 |
| Device Name: | GAMMA MED II |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-24 |
| Decision Date | 1978-08-10 |