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FDA 510(k) Application Details - K123917
Device Classification Name
Probe, Uptake, Nuclear
More FDA Info for this Device
510(K) Number
K123917
Device Name
Probe, Uptake, Nuclear
Applicant
SURGICEYE GMBH
Friedenstr. 18a
Munich 81671 DE
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Contact
MORITZ HOYER
Other 510(k) Applications for this Contact
Regulation Number
892.1320
More FDA Info for this Regulation Number
Classification Product Code
IZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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