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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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full automatic (nibp) blood pressure monitor, model hl168kb Health & Life Co., Ltd. k092163 11/16/2009
disposable trocars Hangzhou Kangji Medical Instrument Co., Ltd. k233263 04/09/2024
pristine/blooming/pristine blooming culture cath Hall/Mccollum Laboratories, Inc. k862098 11/12/1986
powder free latex examination gloves, blue, tested for use with chemotherapy drugs Gx Corporation Sdn Bhd k091643 11/02/2009
clearvision nuclear medicine imaging system Gvi Technology Partners k072191 10/25/2007
guthrie powderfree latex examination gloves Guthrie Medicare Products (Melaka) Sdn Bhd k954967 04/15/1996
cmv test Gull Laboratories, Inc. k853137 11/14/1985
accunet embolic protection system, rx accunet embolic protection system Guidant Corp. k042218 08/31/2004
life trace trans tip intrauterine pressure catheter Graphic Controls Corp. k950498 07/24/1995
zip'r mantis powered wheelchair Global Fabtech Wheelchair (Shanghai) Co., Ltd. k102355 10/04/2010

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