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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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bact/alert mb culture bottle ORGANON TEKNIKA CORP. k000378 03/02/2000
bardex i.c.plus foley catheter with silver salts in hydrogel coating, model 3cc balloon: 17008,170010,5cc balloon C.R. BARD, INC. k002612 09/03/2002
baumer femoral head BAUMER S.A. k001571 08/04/2000
bayer advia ims system; 200 + 3 BAYER CORP. k000921 05/18/2000
bd probetec et mycobacterium tuberculosis complex (ctb) culture identification assay BECTON DICKINSON BIOSCIENCES k000884 01/19/2001
betel powder free latex exam gloves BETELCARE SDN BHD k000650 04/20/2000
betel powder free latex exam gloves, chlorinated, with protein labeling claim (50 micrograms or less) BETELCARE SDN BHD k000652 04/10/2000
bi-phasic infiltrator RELIANCE MEDICAL CORP. k012044 08/28/2001
bilichek non-invasive bilirubin analyzer SPECTRX, INC. k994438 02/04/2000
bio-lipid human serum hdl and ldl calibrators BIOCELL LABORATORIES, INC. k000056 02/24/2000

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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