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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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91 to 100 of 416 results
Decision Date To: 05/28/2024
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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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POMC/PCSK1/LEPR CDx Panel PreventionGenetics, LLC DEN200059 01/21/2022
Sunrise Sleep Disorder Diagnostic Aid Sunrise DEN210015 01/07/2022
CavaClear Laser Sheath Spectranetics, Inc. DEN210024 12/21/2021
Comfort Marker 2.0. Medical Precision B.V. DEN200041 12/10/2021
Klox Biophotonic LumiHeal System Klox Technlogies Inc. DEN200005 12/03/2021
vPatch Virility Medical DEN210012 11/23/2021
EaseVRx AppliedVR, Inc. DEN210014 11/16/2021
Hemolung Respiratory Assist System ALung Technologies, Inc. DEN210006 11/13/2021
OMNIgene GUT Dx DNA Genotek Inc. DEN200040 11/03/2021
Luminopia One Luminopia, Inc. DEN210005 10/20/2021
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