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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 K170203
Device Name System, Applicator, Radionuclide, Remote Controlled
Applicant
Kobold, LLC
23403 E. Mission Ave.
Suite 220e
Liberty Lake,  WA  99019
Applicant Contact Deanna Hughes
Correspondent
Kobold, LLC
23403 E. Mission Ave.
Suite 220e
Liberty Lake,  WA  99019
Correspondent Contact Deanna Hughes
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received01/23/2017
Decision Date 06/01/2017
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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