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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Uptake, Nuclear
510(k) Number K101887
Device Name CONFIDENT SURGERY SUITE 300, MODEL CSS300
Applicant
Surgiceye GmbH
Friedenstrasse 18a
Munich, Bavaria,  DE 81671
Applicant Contact MORITZ HOYER
Correspondent
Surgiceye GmbH
Friedenstrasse 18a
Munich, Bavaria,  DE 81671
Correspondent Contact MORITZ HOYER
Regulation Number892.1320
Classification Product Code
IZD  
Date Received07/06/2010
Decision Date 03/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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