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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 K022635
Device Name KUSKE BREAST APPLICATOR SET, MODEL 189.006
Applicant
Nucletron Corporation
7080 Columbia Gateway Dr.
Columbia,  MD  21046 -2133
Applicant Contact LISA DIMMICK
Correspondent
Nucletron Corporation
7080 Columbia Gateway Dr.
Columbia,  MD  21046 -2133
Correspondent Contact LISA DIMMICK
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received08/08/2002
Decision Date 09/06/2002
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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