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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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31 to 40 of 416 results
Decision Date To: 06/10/2024
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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
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Dream Sock Owlet Baby Care, Inc. DEN220091 11/08/2023
EasySep™ Human Bone Marrow CD138 Positiv STEMCELL Technologies Canada Inc. DEN220090 11/06/2023
Edison System HistoSonics, Inc. DEN220087 10/06/2023
Stanza Swing Therapeutics, Inc. DEN220083 05/09/2023
Breast Implant Removal Device (BIRD) Gaylord Solutions, LLC DEN220082 04/20/2023
Eroxon Futura Medical Developments Limited DEN220078 06/09/2023
Revi System BlueWind Medical Ltd. DEN220073 08/16/2023
BrainSee Darmiyan, Inc. DEN220066 01/11/2024
Pill Sense System EnteraSense Ltd. DEN220065 02/24/2023
Caption Interpretation Automated Ejectio Caption Health, Inc DEN220063 02/24/2023
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