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FDA 510(k) Application Details - K101887
Device Classification Name
Probe, Uptake, Nuclear
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
892.1320
More FDA Info for this Regulation Number
Classification Product Code
IZD
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More FDA Info for this Product Code
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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