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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 K020015
Device Name IMPLANT GUIDANCE SYSTEM APPLICATOR SET
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 Received01/03/2002
Decision Date 03/13/2002
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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