SEGMENTED VAGINAL 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 Segmented Vaginal Applicator.

Pre-market Notification Details

Device IDK993472
510k NumberK993472
Device Name:SEGMENTED VAGINAL APPLICATOR
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant MICK RADIO-NUCLEAR INSTRUMENTS, INC. 1470 OUTLOOK AVE. P.O. BOX 99 Bronx,  NY  10465
ContactFelix Mick
CorrespondentFelix Mick
MICK RADIO-NUCLEAR INSTRUMENTS, INC. 1470 OUTLOOK AVE. P.O. BOX 99 Bronx,  NY  10465
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-14
Decision Date2000-01-12
Summary:summary

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