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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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pdc 304 double swab culture collection PRECISION DYNAMICS CORP. k791953 10/30/1979
automatic screening audiometer POSITRON k810537 03/11/1981
paramedic o2 kit POHLMANN RESCUE PRODUCTS, INC. k780168 04/18/1978
headlights w/ filter-optico cables PILLING CO. k761142 01/05/1977
intellivue patient monitors with release c.02, models mp20, mp30, mp40, mp50, mp60, mp70, mp80 and mp90 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH k052801 11/02/2005
ultrasim ct system PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. k001088 06/22/2000
philips page writer trim series cardiograph including i, ii, iii, models 860286, 860287, 860288, 860289, 860290, 860291 PHILIPS MEDICAL SYSTEMS k031422 07/03/2003
intellivue mx40 patient monitor PHILIPS MEDICAL SYSTEMS k113125 11/17/2011
varelisa b2 glycoprotein i antibodies screen, models 19048 and 19096 PHARMACIA DEUTSCHLAND GMBH k040452 05/11/2004
e-vac blood culture system PFIZER PHARMACEUTICALS k802408 10/23/1980

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