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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 K111931
Device Name GLIASITE RTS
Applicant
Isoray Medical, Inc.
350 Hills St., Suite 106
Richland,  WA  99354 -5411
Applicant Contact FREDRIC G SWINDLER
Correspondent
Isoray Medical, Inc.
350 Hills St., Suite 106
Richland,  WA  99354 -5411
Correspondent Contact FREDRIC G SWINDLER
Regulation Number892.5730
Classification Product Code
KXK  
Date Received07/08/2011
Decision Date 08/05/2011
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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