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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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71 to 80 of 415 results
Decision Date To: 05/22/2024
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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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Sonablate 450 SonaCare Medical, LLC. DEN150011 10/09/2015
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Quidel Corporation DEN220039 03/08/2023
SNOO Smart Sleeper Happiest Baby, Inc. DEN210039 03/30/2023
SNAP WOUND CARE DEVICE SPIRACUR, INC. DEN080011 K081406 08/07/2009
Sleep Apnea Feature Samsung Electronics Co., Ltd DEN230041 02/06/2024
SkinPen Precision System BELLUS MEDICAL, LLC. DEN160029 03/01/2018
SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS DEN130049 K133621 03/21/2014
Simple 2 Test LetsGetChecked Inc. (formerly PrivaPath DEN200070 11/15/2023
Sepsis ImmunoScore Prenosis, Inc. DEN230036 04/02/2024
Sepax Cell Separation System and Single Biosafe SA BK060036 01/03/2007
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