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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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fresenius viral blocking transducer protector for hemodialysis, model 04-9500-2 Fresenius Medical Care North America k003445 12/01/2000
plastic elastomer encased in terry cloth Fred Sammons, Inc. k823619 12/22/1982
sympulse computer system for fonar mri scanners Fonar Corp. k003453 01/18/2001
fisher diag. prime blood gas controls Fisher Scientific Co., LLC k792143 11/13/1979
exel i.v. administration set Exelint Intl. Co. k010404 08/30/2001
visio-gem Espe GmbH (Us) k833757 02/03/1984
dimension garant l, dimension garant l quick Espe Dental AG k000588 03/30/2000
filtryzer hollow fiber artif. kidney Erika, Inc. k831175 06/22/1984
polaris x catheters, model 7000d,7001d,7003d,7004d,7005d,7006d Ep Technologies, Inc. k003452 12/07/2000
sterichek total chlorine reagent strips Environmental Test Systems, Inc. k001194 07/11/2000

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