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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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central venous catheter BOSTON SCIENTIFIC CORP. k003839 08/01/2001
exactrac 3rd party, exactrac x-ray 6d 3rd party, exactrac oem BRAINLAB AG k072046 10/17/2007
phipiological synchronizer part#205 BRATTLE INSTRUMENT CORP. k781681 10/17/1978
brightway brand powder free latex examination gloves, blue non-sterile, protein labeling claim (50 micrograms or less) ( BRIGHTWAY HOLDINGS SDN. BHD. k011728 07/09/2001
franklin quantic 1200 BRUCE FRANKLIN, INC. k822236 08/31/1982
liberator/stroller BURDITT & CALKINS-SIEMENS-ELEMA k760787 10/22/1976
optifix at absorbable fixation system with articulating technology - 30 fasteners, optifix at absorbable fixation system with articulating technology - 15 fasteners C.R. BARD INC. k170278 05/31/2017
phasix st mesh with open positioning system C.R. Bard, Inc. k190185 06/12/2019
ria sys. for human growth hormone CALBIOCHEM-BEHRING CORP. k780347 04/12/1978
sapcrill thermodetect breast scanner dev CALIFORNIA CARDIAC SYSTEMS, INC. k801573 09/09/1980

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