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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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anastomart(tm) coronary bypass graft markers/modif Pioneering Technologies, Inc. k922025 09/22/1992
arix foot system Jeil Medical Corporation k131311 09/05/2013
arm automatic reprocessing machine Alcavis International Incorporated k013713 07/15/2002
arrhythmia central occ-7101 Nihon Kohden America, Inc. k843287 10/18/1984
arrythmia printer option American Edwards Laboratories k811792 07/10/1981
arthrex fibertak suture anchor Arthrex, Inc. k203268 11/27/2020
artus disposable sheaths/cutters Acufex Microsurgical, Inc. k880881 05/04/1988
asst-3000 spinal surgery table Orthopedic Systems, Inc. k883457 08/26/1988
atlantic optical systems optifilter system Atlantic Optical Systems, Inc. k850533 03/21/1985
aution jet aj-4270 urine analyzer International Remote Imaging Systems k030600 07/11/2003

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