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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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omnistim continence+ pelvic floor stimulation system ACCELERATED CARE PLUS k093600 12/04/2009
ambu neuroline disposable inoject needle electrode AMBU A/S k093825 01/13/2010
biofoam bone wedge model assorted WRIGHT MEDICAL TECHNOLOGY, INC. k093950 01/22/2010
powder-free vinyl patient examination gloves TANGSHAN HONGDA PLASTCI PRODUCTS CO LTD k100326 03/24/2010
polaris spinal system, polaris/synergy structue anterior fixation system BIOMET SPINE (AKA EBI, LLC) k100409 06/23/2010
fiber one AMERICAN MEDICAL SYSTEMS k100746 06/11/2010
disposable nerve stimulating probe, bipolar concentric, disposable nerve stimulator probe, bipolar side by side KIRWAN SURGICAL PRODUCTS, INC. k100912 08/19/2010
benz-g 4x (hioxifilcon d) multifocal lathed lens BENZ RESEARCH AND DEVELOPMENT CORP. k101122 08/09/2010
tgs unicompartmental knee arthroplasty (tgs uka) modular tibia system ALEXANDRIA RESEARCH TECHNOLOGIES, LLC k101206 07/23/2010
powder-free vinyl patient examination gloves HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. k101358 08/24/2010

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