VAGINAL APPLICATOR SHIELDED

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 Vaginal Applicator Shielded.

Pre-market Notification Details

Device IDK001544
510k NumberK001544
Device Name:VAGINAL APPLICATOR SHIELDED
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 Received2000-05-18
Decision Date2000-11-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817330024022 K001544 000
00817330021489 K001544 000
00817330021496 K001544 000
00817330021502 K001544 000
00817330021519 K001544 000
00817330021526 K001544 000
00817330021533 K001544 000
00817330021540 K001544 000
00817330021557 K001544 000
00817330021564 K001544 000
00817330021571 K001544 000
00817330022974 K001544 000
00817330023964 K001544 000
00817330023971 K001544 000
00817330023988 K001544 000
00817330023995 K001544 000
00817330024008 K001544 000
00817330024015 K001544 000
00817330021472 K001544 000

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