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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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510(K)
Number
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Decision
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total protein reagent biuret Reagents Applications, Inc. k841466 05/16/1984
toraysulfone dialyzer, bs-l series Toray Industries (America), Inc. k030050 09/29/2003
tonsil dissectors Kelleher Corp. k822187 08/24/1982
themo-flo system 3 laparoscopic/hysteroscopic system Sanese Medical Corp. k941507 03/06/1995
the uric acid reagent set Macomb Biotechnology, Inc. k871902 06/03/1987
the suad device Strong Dental, Inc. k023836 07/08/2003
the phillips, model mp20,mp30,mp40,mp50,mp60,mp70,mp80,and mp90 intellivue patient monitors Philips Medizin Systeme Boeblingen GmbH k060221 02/17/2006
the extractor(tm) Molecular Biosystems, Inc. k873932 11/20/1987
the core (cardiac outpatient realtime ecg) monitor Applied Cardiac Systems, Inc. k103706 08/24/2011
the alberta lens sm2, sulfocon b Progressive Optical Research , Ltd. k010454 08/01/2001

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