CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem And Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator S

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 Ct F/s/d Compatible Applicators (fletcher), Hdr Compatible Tandem And Ovoid Applicators (henschke), Hdr Ct Compatible Split Ring Applicator, Segmented Vaginal Applicator, Hdr Miami Applicator Hdr Brachytherapy Applicator, 2/3 Endometrial Applicator S.

Pre-market Notification Details

Device IDK200221
510k NumberK200221
Device Name:CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem And Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator S
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon,  NY  10550
ContactJames Hurlman
CorrespondentJames Hurlman
Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon,  NY  10550
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-29
Decision Date2020-02-28

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