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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 K021286
Device Name MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES
Applicant
Nucletron Corp.
7080 Columbia Gateway Dr.
Columbia,  MD  21046
Applicant Contact LISA DIMMICK
Correspondent
Nucletron Corp.
7080 Columbia Gateway Dr.
Columbia,  MD  21046
Correspondent Contact LISA DIMMICK
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received04/23/2002
Decision Date 05/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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