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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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Decision
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flexible choledochoscope (model: cs50h-20eu, cs50h-20us) Shanghai AnQing Medical Instrument Co., Ltd k231105 10/17/2023
synthetic nitrile patient examination gloves, powder free, blue color, and tested for use with chemotherapy drugs SHANDONG FEIYANG PROFESSIONAL GLOVES CO., LTD k170136 08/25/2017
integra oxygen concentrators model 6400-om SEQUAL TECHNOLOGIES, INC. k003472 06/04/2001
electrosurgical generator system, model es 3000 SENORX, INC. k052857 10/21/2005
scivolutions various antibacterial bandages SCIVOLUTIONS, INC k020318 02/03/2003
anterior/posterior restorative, bond SCIENTIFIC PHARMACEUTICALS, INC. k791078 08/10/1979
hbs headless bone screw SCHOENING & ASSOC., INC. k030302 08/08/2003
model iii handswitch SARA DAN, INC. k792600 01/10/1980
total & direct bilirubin procedures SANDARE CHEMICAL CO., INC. k832942 11/07/1983
rs-4i muscle stimulator RS MEDICAL k112348 01/19/2012

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