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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)
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Decision
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brentwood iqmark digital spirometer (includes disposable pneumotach mouthpieces and 3-liter calibration syringe Brentwood Medical Technology Corp. k002499 11/08/2000
breathing filter for disposable anesthesia breathing circuit Sims Portex, Inc. k002506 12/14/2000
brandt tracheal tube(tentative) Mallinckrodt Critical Care k852025 08/13/1985
brachysciences strandport Worldwide Medical Technologies, LLC k062214 03/01/2007
boucher degroot head positioning glasses, model 8080 Labtician Ophthalmics, Inc. k000544 03/09/2000
bonesave bone void filler Howmedica Osteonics k033258 03/09/2004
blood pump-mode s10k 3M Health Care, Sarns k780410 05/03/1978
bioz.pc hemodynamic monitor model bz-500/bz-501; bioz.pc user software installation kit model bz-810 Cardiodynamics International Corp. k001081 06/30/2000
biover Biover AG k011208 10/02/2002
biocurve soft (methafilcon a) spherical and toric soft contact lens for daily wear (clear, lathe-cut) American Contact Lens, Inc. k010223 03/16/2001

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