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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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321 to 330 of 416 results
Decision Date To: 06/01/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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vPatch Virility Medical DEN210012 11/23/2021
Klox Biophotonic LumiHeal System Klox Technlogies Inc. DEN200005 12/03/2021
Comfort Marker 2.0. Medical Precision B.V. DEN200041 12/10/2021
CavaClear Laser Sheath Spectranetics, Inc. DEN210024 12/21/2021
Sunrise Sleep Disorder Diagnostic Aid Sunrise DEN210015 01/07/2022
POMC/PCSK1/LEPR CDx Panel PreventionGenetics, LLC DEN200059 01/21/2022
ONE Male Condom Global Protection Corp. DEN210034 02/23/2022
BrainTemp Neonate System (BTNeo System) Brain Temp Inc. DEN200042 03/29/2022
BioFire Joint Infection (JI) Panel BioFire Diagnostics, LLC DEN200066 04/29/2022
Kerasave AL.CHI.MI.A. S.r.l DEN200063 05/02/2022
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