FDA 510(k) Application Details - K101887

Device Classification Name Probe, Uptake, Nuclear

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510(K) Number K101887
Device Name Probe, Uptake, Nuclear
Applicant SURGICEYE GMBH
FRIEDENSTRASSE 18A
MUNICH, BAVARIA 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 07/06/2010
Decision Date 03/22/2011
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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