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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 K142330
Device Name Kobold Ring and Tandem Applicator Set
Applicant
KOBOLD, LLC
23403 E Mission Ave, Ste 220E
Liberty Lake,  WA  99019
Applicant Contact Spencer Fillmore
Correspondent
KOBOLD, LLC
23403 E Mission Ave, Ste 220E
Liberty Lake,  WA  99019
Correspondent Contact Spencer Fillmore
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received08/20/2014
Decision Date 04/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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