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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 K060299
Device Name ART BRACHYTHERAPY APPLICATOR
Applicant
Advanced Radiation Therapy, LLC
9 Linnell Cir.
Billerica,  MA  01820
Applicant Contact RAYMOND BRICAULT
Correspondent
Advanced Radiation Therapy, LLC
9 Linnell Cir.
Billerica,  MA  01820
Correspondent Contact RAYMOND BRICAULT
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received02/06/2006
Decision Date 06/06/2006
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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