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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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advacoat sinus gel and stent CARBYLAN BIOSURGERY k070496 03/15/2007
advantage 4d option GE MEDICAL SYSTEMS, LLC k032915 10/30/2003
advia 2120 with autoslide system, and advia 2120i SIEMENS HEALTHCARE DIAGNOSTICS k102644 11/23/2011
advia centaur b-type natriuretic peptide (bnp) assay BAYER HEALTHCARE, LLC k031038 06/23/2003
advia centaur vitamin d total assay Siemens Healthcare Diagnostics Inc. k110586 10/14/2011
advia chemistry drug calibrator ii, model 10376771 SIEMENS HEALTHCARE DIAGNOSTICS k090900 06/01/2009
aesculap neuro patties AESCULAP, INC. k062406 09/15/2006
aft greater tuberosity fracture plate, left, aft greater tuberosity fracture plate, right, aft greater tuberosity cannul SHOULDER OPTIONS, INC. k133668 03/03/2014
agcel wound dressing,agcel burn dressing MODERN MEDICAL EQUIPMENT MFG., LTD. k050842 08/02/2006
airgent, model ag7000010 PERFACTION, INC. k082138 01/23/2009

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