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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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global by blastocyst media INTL., INC. k010183 05/02/2001
dynatrac, cod. 50-1a 3D LINE USA, INC. k034051 04/05/2004
3m littmann electronic stethoscope, model 4100 3M COMPANY k051790 07/25/2005
future wash/yps 3M ESPE AG DENTAL PRODUCTS k051797 07/21/2005
bovie button remote hand switch AARON MEDICAL INDUSTRIES k060117 02/22/2006
high silver conventional AB ARDENT k020452 05/07/2002
modification to plum xl infusion pump ABBOTT LABORATORIES k010924 04/06/2001
relieva sinus balloon inflation device ACCLARENT, INC. k052198 08/31/2005
ultegra system rapid platelet function assay - asa (rpfa-asa) ACCUMETRICS, INC. k012701 06/12/2002
autofuser ACE MEDICAL US, LLC k060258 05/30/2006

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