FDA 510(k) Application Details - K123917

Device Classification Name Probe, Uptake, Nuclear

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510(K) Number K123917
Device Name Probe, Uptake, Nuclear
Applicant SURGICEYE GMBH
Friedenstr. 18a
Munich 81671 DE
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Contact MORITZ HOYER
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Regulation Number 892.1320

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Classification Product Code IZD
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Date Received 12/19/2012
Decision Date 01/25/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K123917


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