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FDA 510(k) Application Details - K142330
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
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510(K) Number
K142330
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
KOBOLD, LLC
23403 E Mission Ave, Ste 220E
Liberty Lake, WA 99019 US
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Contact
Spencer Fillmore
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Regulation Number
892.5700
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Classification Product Code
JAQ
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Date Received
08/20/2014
Decision Date
04/09/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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