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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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171 to 180 of 413 results
Decision Date To: 05/17/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
Date
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Masimo SafetyNet Masimo Corporation DEN200011 03/31/2023
ORi Masimo Corporation DEN200076 10/12/2023
RESTLESS LEG DEVICE MARY M. SORG (AN INDIVIDUAL) DBA PJ SLEE DEN110009 K102707 12/18/2013
DuraGraft Marizyme, Inc. DEN230002 10/04/2023
INTROL CF PANEL I CONTROL MAINE MOLECULAR QUALITY CONTROLS, INC. DEN060007 K060070 10/12/2006
Parallel Mahana Therapeutics, Inc. DEN200029 11/25/2020
QUICKAIR CHOKE RELIEVER, MODEL 59-001A MAET INDUSTRIES, INC. DEN000004 K993284 02/29/2000
Luminopia One Luminopia, Inc. DEN210005 10/20/2021
ID-TAG RESPIRATORY VIRAL PANEL LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN070013 K063765 01/03/2008
XTAG GASTROINTESTINAL PATHOGEN PANEL (GP LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN130003 K121454 01/14/2013
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