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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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Decision
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latex examination gloves Jiahn Chiaur Enterprise Co., Ltd. k894195 07/28/1989
sysmex r-1000 automated reticulocyte analyzer Toa Medical Electronics USA, Inc. k894539 09/26/1989
protologic model ser-1 Protologic, Inc. k894936 01/22/1990
flexible fiber-optic nasopharyngoscope Optimed Technologies, Inc. k895245 11/17/1989
primidone (fpia) calibrator kit Tudor Laboratories, Inc. k895568 09/28/1989
vita cerec set and vita cerec blocs Vident k895901 01/17/1992
dahlberg model lp behind-the-ear hearing aid Dahlberg Electronics, Inc. k896159 01/22/1990
nova gel(tm) t scl-70 Inova Diagnostics, Inc. k896461 11/20/1989
micro dau cocaine metabolite test kit Immunotech Corp. k896781 03/23/1990
thayer semi-rigid condensate collection system Thayer Medical Corp. k897057 03/16/1990

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