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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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hem ave-toxo screening hemagglutination test kit Si Sero-Immuno Diagnostics, Inc. k851976 10/16/1985
harmony line kf Ivoclar North America, Inc. k951297 04/18/1995
handheld vitalsigns monitoring system Visiomed Technology Co.,Ltd k172965 12/17/2018
haida model hd11 manual wheelchair Jiangyin East China Medical Technology Co., Ltd. k082274 08/19/2008
h 10 or hematil 10 blood cell & platelet counter Texas Intl. Laboratories, Inc. k883177 11/30/1988
gx-c cephalometer Gendex Corp. k920189 04/28/1992
guthrie powderfree latex examination gloves Guthrie Medicare Products (Melaka) Sdn Bhd k954967 04/15/1996
guinea pig blood in alsever's, cit., def Dutchland Laboratories, Inc. k812372 09/09/1981
guide wire introducer Target Therapeutics k873972 04/01/1988
graspers & scissors (minimal access surg instr) Conmedcorp k924469 04/07/1993

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