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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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formalens 2000 Vision-Sciences, Inc. k863367 09/26/1986
ez-mio manual driver Vidacare Corporation k052195 11/02/2005
new allergen discs for use in vast vent Ventrex Laboratories, Inc. k830817 04/27/1983
dardik carotid shunt Vascutech, Inc. k001621 12/06/2000
proton vision 7.0 Varian Medical Systems, Inc. k002312 08/30/2000
fowler endocurette, model cur-xxx Utah Medical Products, Inc. k000974 05/23/2000
magna 5000 phased array ctl spine coil Usa Instruments, Inc. k000002 02/23/2000
liberty 9000 breast coil Usa Instruments, Inc. k000993 05/26/2000
uro-g hd flexible cystoscope Uroviu Corporation k232837 06/07/2024
hearing aid model e1-pl Unitron Industries, Inc. k811286 06/16/1981

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