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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)
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Decision
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connect app for ihealth next, ihealth react native sdk, ihealth react native library sdk, ihealth library sdk, ihealth native sdk Andon Health Co, Ltd. k181541 04/16/2019
contain(tm) laser plume filter Arbor Technologies, Inc. k902167 01/04/1991
cordis angiographic doppler cather Cordis Corp. k915498 04/17/1992
corning 2500 co-oximeter Corning Medical & Scientific k830590 04/05/1983
cosmedtech cannula Cosmedtech, Inc. k870560 03/04/1987
cosmos Pausch Corp. k870856 03/30/1987
cpap infant nasal cannulae set Ackrad Laboratories k823936 01/28/1983
cranex novus Soredex Palodex Group OY k063459 12/26/2006
creatinine reagent Derma Media Lab., Inc. k955938 03/12/1996
culture-pak collection and transport system Medical Packaging Corp. k932337 08/16/1994

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