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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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151 to 160 of 413 results
Decision Date To: 05/17/2024
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Download Files | More About De Novo
Device Name
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De Novo
Number
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510(k)
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Decision
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Cereve Sleep System CEREVE, INC. DEN140032 05/13/2016
WallFlex Biliary RX Fully Covered Stent BOSTON SCIENTIFIC DEN150040 06/03/2016
PEDIATRIC VISION SCANNER REBISCAN, INC. DEN130051 06/08/2016
Magnetic Surgical System Levita Magnetics International Corp. DEN150007 06/13/2016
EPIC ClearView System EPIC RESEARCH & DIAGNOSTICS, INC. DEN150004 07/15/2016
Quantidex qPCR BCR-ABL IS Kit ASURAGEN, INC. DEN160003 07/22/2016
Permaseal MICRO INTERVENTIONAL DEVICES, INC. DEN150029 07/27/2016
Nautilus BrainPulse 1000 JAN MEDICAL, INC. DEN140040 08/01/2016
ImPACT Computerized Neurocognitive Concu IMPACT APPLICATIONS, INC. DEN150037 08/22/2016
Modified Trevo ProVue Retriever, Trevo X CONCENTRIC MEDICAL, INC. DEN150049 09/02/2016
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