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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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smart control nitinol stent transhepatic biliary system CORDIS CORP. k021898 08/14/2002
slicks sectional matrix and matrix bands, models sm100, sm150, sm175, sm200, sm300, smh100, smh150, smh175 and smh200 GARRISON DENTAL SOLUTIONS k091533 08/17/2009
skylark uro probe SKYLARK DEVICE & SYSTEMS CO., LTD k053007 12/05/2005
simulix-evolution with oncentra conebeam NUCLETRON CORPORATION k052361 10/24/2005
signum J.F. JELENKO & CO., INC. k001360 06/20/2000
siemens virtual simulation (vsim) SIEMENS MEDICAL SOLUTIONS USA, INC. k022036 11/05/2002
siemens infinity modular monitors, models sc 8000, sc 7000 and sc 9000xl, with scio SIEMENS MEDICAL SOLUTIONS USA, INC. k031340 11/25/2003
sidexis 4 SIRONA DENTAL SYSTEMS GMBH k132773 12/11/2013
sidestream plus RESPIRONICS LTD. k062689 02/16/2007
shiga toxin chek TECHLAB INC., CORPORATE RESEARCH CENTER k121411 10/02/2012

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