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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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131 to 140 of 417 results
Decision Date To: 06/21/2024
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Device Name
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De Novo
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510(k)
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Decision
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Enlight 1810 Timpel Inc. DEN170072 12/20/2018
ensoETM Advanced Cooling Therapy, Inc. d/b/a Att DEN230021 09/13/2023
Eonis SCID-SMA Kit PerkinElmer Inc. DEN200044 11/09/2022
EPIC ClearView System EPIC RESEARCH & DIAGNOSTICS, INC. DEN150004 07/15/2016
ERCHONIA ML SCANNER (MLS) ERCHONIA MEDICAL DEN090008 K082609 08/24/2010
EROS-CLITORAL THERAPY DEVICE (CTD) UROMETRICS, INC. DEN000006 K000280 04/28/2000
Eroxon Futura Medical Developments Limited DEN220078 06/09/2023
esolution S4 Medical Corp DEN230006 09/06/2023
ESOPHAGEAL COOLING DEVICE ADVANCED COOLING THERAPY, LLC DEN140018 06/23/2015
EUROIMMUN ANTI-PLA2R IFA EUROIMMUN US DEN140002 K132379 05/29/2014
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