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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 K062384
Device Name CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
Applicant
Isoray, Inc.
350 Hills St., Suite 106
Richland,  WA  99354
Applicant Contact DAVID J SWANBERG
Correspondent
Isoray, Inc.
350 Hills St., Suite 106
Richland,  WA  99354
Correspondent Contact DAVID J SWANBERG
Regulation Number892.5730
Classification Product Code
KXK  
Date Received08/15/2006
Decision Date 11/09/2006
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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