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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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hematrak maturity profile option Geometric Data, Div. Smithkline Corp. k761208 02/28/1977
gx-c cephalometer Gendex Corp. k920189 04/28/1992
48ch head coil Ge Healthcare Coils (Usa Instruments, Inc.) k180666 04/12/2018
fiber hemofilters fh55-fh77 & 88 Gambro, Inc. k840720 04/24/1984
fdr d-evo gl flat panel detector system Fujifilm Medical System U.S.A., Inc. k152138 11/05/2015
digital intraoral imaging plate system Fsusen Technology Co., Ltd. k192766 12/05/2019
2 velcro splint strap Fred Sammons, Inc. k790182 02/15/1979
neuroflax, epk Franks Electronics k831990 11/28/1983
s500 seating system Fortress Scientific , Ltd. k933863 03/28/1994
gentamicin sulfate solution (50mg gentamicin) Flow Laboratories, Inc. k861823 05/20/1986

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