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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K003206
Device Name GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
Applicant
Proxima Therapeutics, Inc.
2555 Marconi Dr., Suite 220
Alpharetta,  GA  30005
Applicant Contact DEBORAH J MOORE
Correspondent
Proxima Therapeutics, Inc.
2555 Marconi Dr., Suite 220
Alpharetta,  GA  30005
Correspondent Contact DEBORAH J MOORE
Regulation Number892.5730
Classification Product Code
KXK  
Subsequent Product Code
IWJ  
Date Received10/13/2000
Decision Date 04/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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