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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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syncvision system Volcano Corporation k172574 10/05/2017
neo pedicle screw system™ Neo Medical S.A. k171582 09/12/2017
arzzt 3.5 / 4.5 small & large fragments system TRUEMED GROUP, LLC k162507 08/03/2017
arrow seldinger arterial catheterization device 18 ga., arrow seldinger arterial catheterization device 20 ga., arrow seldinger arterial catheterization device 22 ga., arrow seldinger arterial catheterization device 24 ga. Arrow International, Inc. (Subsidiary of Telelflex Inc.) k171146 06/23/2017
spira open matrix alif CAMBER SPINE TECHNOLOGIES k162986 06/12/2017
gtk disposable needle guides GEOTEK Medikal Ltd Sti k170741 06/01/2017
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
nova statsensor creatinine hospital meter system Nova Biomedical Corporation k171059 05/26/2017
aik sterile acupuncture needles for single use CHANGCHUN AIK MEDICAL DEVICES CO., LTD k162566 05/11/2017
verify assert steam process challenge device for gravity cycles STERIS Corporation k170070 04/28/2017

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