GAMMAMED IRIDIUM-192 SOURCE

System, Applicator, Radionuclide, Remote-controlled

MICK RADIO-NUCLEAR INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Gammamed Iridium-192 Source.

Pre-market Notification Details

Device IDK894381
510k NumberK894381
Device Name:GAMMAMED IRIDIUM-192 SOURCE
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant MICK RADIO-NUCLEAR INSTRUMENTS, INC. P.O. BOX 99 Bronx,  NY  10465
ContactAdel J Holl
CorrespondentAdel J Holl
MICK RADIO-NUCLEAR INSTRUMENTS, INC. P.O. BOX 99 Bronx,  NY  10465
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-17
Decision Date1989-11-21

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