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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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Decision Date To: 07/02/2019 De Novo Products: yes
 
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Device Name
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De Novo
Number
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510(k)
Number
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Decision
Date
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Hearing Aid Feature (HAF) Apple Inc. DEN230081 09/12/2024
Chronos® Germitec DEN230067 08/28/2024
First To Know Syphilis Test NOWDiagnostics DEN230090 08/16/2024
SoClean 3+ Bacterial Reduction Device SoClean, Inc. DEN210037 08/12/2024
PGDx elio plasma focus Dx Personal Genome Diagnostics, Inc. DEN230046 08/01/2024
allay Nerve Cap Tulavi Therapeutics DEN230061 07/16/2024
Simplexa C. auris Direct, Simplexa C. au DiaSorin Molecular LLC DEN230092 07/15/2024
Terragene Bionova Photon Biological Indi Terragene SA DEN220042 07/12/2024
MagDI System GT Metabolic Solutions, Inc. DEN240013 07/02/2024
BioHealx Anal Fistula Device Signum Surgical Limited DEN240007 07/01/2024
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