HDR IORT SHIELDED APPLICATOR

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 Hdr Iort Shielded Applicator.

Pre-market Notification Details

Device IDK052351
510k NumberK052351
Device Name:HDR IORT SHIELDED APPLICATOR
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon,  NY  10550
ContactFelix Mick
CorrespondentFelix Mick
MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon,  NY  10550
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-29
Decision Date2005-10-17
Summary:summary

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