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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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orthosize ORTHOSIZE LLC k120115 03/14/2012
lavatory seat heightener ORTHION CORP. k823155 11/05/1982
influenza a & b s-antigen & controls ORION DIAGNOSTICA, INC. k802931 01/12/1981
bc-001+ acne purifier Oriental Inspiration Limited k170260 04/25/2017
the aio solution 3.0 Orfit Industries NV k202068 08/14/2020
lifestent sds and xl sds biliary endoprosthesis ORBUS MEDICAL TECHNOLOGIES k040550 03/16/2004
reusable nibp cuff Orantech Inc. k173197 08/21/2018
f1 diode laser system OPUS MEDICAL, INC. k030235 04/23/2003
hem-7311 OMRON HEALTHCARE, INC. k133379 01/16/2014
endoscopic ultrasound center eu-y0008 OLYMPUS MEDICAL SYSTEMS CORP. k130058 02/22/2013

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