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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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bimetric total hip system Biomet, Inc. k921224 02/16/1994
the titanium fixation system Biomedics k943071 01/06/1995
#2001 hektoen Biomedica, Inc. k820798 04/08/1982
biological ohm meter, bes 200z Bioelectrical Sciences, Inc. k880926 06/15/1988
home urodata system(tm) Biodan Medical Systems, Ltd. k900770 06/08/1990
deluxe adjustable height ultrasound table Biodan Medical Systems, Ltd. k922604 10/20/1992
bone marrow collection medium Bioclinical Laboratory Services, Inc. k864740 01/05/1987
sensomat muscle/tissue ph Biochem International, Inc. k803260 02/02/1981
elisa tube tsh test Bio Clinic Co. k921958 07/02/1992
sterile polyisoprene powder free surgical gloves Better Care Plastic Technology Co., Ltd. k171047 06/22/2017

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