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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, applicator, radionuclide, remote-controlled
510(k) Number K200221
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 Sets, CT HDR Ring & Tandem Applicator with Rectal
Applicant
Mick Radio-Nuclear Instruments, Inc.
521 Homestead Avenue
Mount Vernon,  NY  10550
Applicant Contact James Hurlman
Correspondent
Mick Radio-Nuclear Instruments, Inc.
521 Homestead Avenue
Mount Vernon,  NY  10550
Correspondent Contact James Hurlman
Regulation Number892.5700
Classification Product Code
JAQ  
Subsequent Product Code
IWJ  
Date Received01/29/2020
Decision Date 02/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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