The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Multitreat 48.
Device ID | K834308 |
510k Number | K834308 |
Device Name: | MULTITREAT 48 |
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 | 1983-11-04 |
Decision Date | 1984-01-10 |