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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
Date
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spirale drug delivery system ARMSTRONG MEDICAL LTD. k111246 08/10/2012
splint, cockup ORTHOPEDIC SYSTEMS, INC. k770890 05/26/1977
sprotte special nrfit PAJUNK GMBH MEDIZINTECHNOLOGIE k160296 10/27/2016
st aia-pack 25-oh vitamin d, st aia-pack 25-oh vitamin d calibrator set, aia-pack 25-oh vitamin d control set, and st aia-pack 25-oh vitamin d pretreatment set TOSOH BIOSCIENCE, INC. k150270 10/26/2015
stageone knee cement spacer molds Biomet, Inc. k213287 09/02/2022
starband, starlight ORTHOMERICA PRODUCTS, INC. k151147 07/01/2015
sterile polyisoprene powder-free blue surgical gloves with neu-thera emollient coating CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES k111868 09/21/2011
sterile suction catheter w/control CHESIRE LABORATORIES k770233 04/05/1977
stockinette, disposablesurgical ANAGO, INC. k782091 01/10/1979
stockinette, sterile two ply w/pull tabs THE OWENBY CO. k801532 07/28/1980

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