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FDA 510(k) Applications for Medical Device Product Code "ORC"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K123006
NIMBIC SYSTEMS, INC
AIR BARRIER SYSTEM (ABS)
12/20/2013
K092801
NIMBIC SYSTEMS, LLC
ABS BLOWER, ABS NOZZLE, MODEL 1001
05/20/2011
K163455
SURGICUBE INTERNATIONAL B.V.
SurgiCube
09/28/2017
K173349
Toul Meditech AB
Operio
12/20/2017
K153498
TOUL MEDITECH AB
Operio
07/20/2016
K190027
Toul Meditech AB
SteriStay
05/10/2019
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