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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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actiheart RESPIRONICS, INC. k052489 09/27/2005
acuity steerable stylet accessory GUIDANT CORPORATION k053019 03/03/2006
acumatch m-series lpb 12/14 femoral stem EXACTECH, INC. k051858 12/01/2005
advanced urological catheter ENTRACARE, LLC k053429 02/08/2006
advantage workstation 4.3. GE HEALTHCARE k052995 11/08/2005
advia 120 hematology system complete blood count (cbc) method BAYER DIAGNOSTICS CORP. k022668 10/15/2002
advia chemistry alpha-1 antitrypsin assay BAYER DIAGNOSTICS CORP. k031857 09/04/2003
advia chemistry microalbumin controls BAYER HEALTHCARE LLC k052242 10/03/2005
agcel wound dressing,agcel burn dressing MODERN MEDICAL EQUIPMENT MFG., LTD. k050842 08/02/2006
agilent information center software for m3150a and m3153a and agilent m2/m3/m4 compact portable patient monitor AGILENT TECHNOLOGIES, INC. k001057 05/03/2000

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