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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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local report generator Spacelabs, Inc. k904318 12/18/1990
loyon Oculus Innovative Sciences k162217 03/23/2017
lung aerosol unit Cadema Medical Products, Inc. k800023 01/01/1985
m2376a devicelink system Agilent Technologies, Inc. k010453 03/02/2001
mag vita tms therapy system w/theta burst stimulation Tonica Elektronik A/S k173620 08/14/2018
marco standard keratometers Marco Ophthalmic, Inc. k930444 08/09/1993
maxi-tan device National Biological Corp. k864546 01/09/1987
meadow fescue allergen disc Immuno Nuclear Corp. k863098 09/15/1986
medical monofilament sensory screening toool Medical Monofilament Manufacturing k143068 01/14/2015
mediziv spinal needle set Medicia Medical Products k925831 07/16/1993

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