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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 K180515
Device Name GammaTile
Applicant
Isoray Medical, Inc.
350 Hills St., Suite 106
Richland,  WA  99354
Applicant Contact Bill Joy
Correspondent
Isoray Medical, Inc.
350 Hills St., Suite 106
Richland,  WA  99354
Correspondent Contact Bill Joy
Regulation Number892.5730
Classification Product Code
KXK  
Date Received02/27/2018
Decision Date 07/06/2018
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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