The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for H.a.m. Applicator.
Device ID | K961601 |
510k Number | K961601 |
Device Name: | H.A.M. APPLICATOR |
Classification | System, Applicator, Radionuclide, Remote-controlled |
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 | JAQ |
CFR Regulation Number | 892.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-25 |
Decision Date | 1996-12-23 |
Summary: | summary |