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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)
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Decision
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quadrox-i small adult with and without intergrated arterial filter with softline coating, models hmo 50000, hmo 51000 MAQUET CARDIOPULMONARY AG k090689 10/29/2009
q-stress and heartstride, models qstress/q40 and h4/h4s CARDIAC SCIENCE CORPORATION k082173 08/26/2008
puritan bennett legendair xl2 NELLCOR PURITAN BENNETT k070899 12/13/2007
pulse oximeter HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD. k141105 12/04/2014
pulpdent trans oba orthodontic bracket adhesive PULPDENT CORP. k014059 02/27/2002
provent professional sleep apnea therapy (provent 80); provent professional sleep apnea therapy (provent 50) VENTUS MEDICAL, INC. k102404 12/02/2010
pronto v3 extraction center, model 5003, pronto lp extraction catheter, model 5010, skyway rx support catheter, VASCULAR SOLUTIONS, INC. k083784 03/30/2009
profix flex cruciate retaining articular insert SMITH & NEPHEW, INC. k051229 07/20/2005
prism zirconia, st-98 A & D DENTAL INNOVATIONS k141659 10/09/2014
primalok facet fixation system OSTEOMED L.P. k102438 09/30/2010

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