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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 K230155
Device Name Mick Valencia Applicator Set
Applicant
Mick Radio-Nuclear Instruments, Inc.
521 Homestead Ave.
Mt. Vernon,  NY  10550
Applicant Contact James Hurlman
Correspondent
Mick Radio-Nuclear Instruments, Inc.
521 Homestead Ave.
Mt. Vernon,  NY  10550
Correspondent Contact James Hurlman
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received01/19/2023
Decision Date 08/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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