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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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rusch miller-abbott tube Rusch Intl. k010797 02/26/2002
scented menstrual pads Procter & Gamble Mfg. Co. k811868 07/16/1981
screeners barbiturate test, drugscreen dip barbiturate test Drug Detection Devices, Ltd. k000522 04/18/2000
sculpture flow Jeneric/Pentron, Inc. k001623 07/11/2000
sd-900 oscillometric bp monitor Industrial & Biomedical Sensors Corp. k802218 10/23/1980
sealouette fibrin sealant extended droplet applicator, model te-1 Biosurgical Corp. k000048 01/31/2000
sebutape Cuderm Corp. k840096 08/02/1984
secret line up (fc1938e80 fc1950e90 fc1960e100 fc1970e120 fc1990e150 fc19100e150 fc19100e280 fc19100e420 fc2038e80 fc2050e90 fc2060e100 fc2070e120 fc2090e150 fc20100e170 fc2138g80 fc2150g90 fc2160g100 fc2170g120 fc2190g150 fc21100g170 fcl18100c160 fcl1938e80 fcl1950e90 fcl1960e100 fcl1970e120 fcl1990e150 fcl19100e160 fcl2138g80 fcl2150g90 fcl2160g100 fcl2170g120 fcl2190g150 fcl21100g160 fcrl1870c162 fcrl18100c185 fcrl1970e162 fcrl19100e185 fchl1960e90 fchl1970e120 fchl19100e160 fcw1938 Hyundae Meditech Co., Ltd. k242571 09/27/2024
selectron ldr selectron low dose rate Radiochemical Co. k844714 02/26/1985
sensititre 18-24 hour mic or breakpoint susceptibility system with lefamulin in the dilution range of 0.008-16ug/ml Thermo Fisher Scientific k192729 11/06/2019

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