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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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91 to 100 of 415 results
Decision Date To: 05/24/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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ContaCT Viz.Al, Inc. DEN170073 02/13/2018
ContainOR Advanced Surgical Concepts Ltd. DEN170075 12/19/2017
Control-IQ Technology Tandem Diabetes Care, Inc. DEN190034 12/13/2019
Cue COVID-19 Molecular Test Cue Health Inc. DEN220028 06/06/2023
Curetis Unyvero LRT Application Curetis GmbH DEN170047 04/03/2018
Curve Positive Airway Pressure System FRESCA Medical DEN170089 06/05/2018
CYTOSCAN(R) DX Affymetrix, Inc. DEN130018 K130313 01/17/2014
D2 Dressing Z-MEDICA, LLC DEN160012 06/30/2017
DECAPINOL ORAL RINSE SINCLAIR PHARMACEUTICALS LIMITED DEN050001 K041482 04/18/2005
DEKA ARM SYSTEM DEKA INTEGRATED SOLUTIONS CORPORATION DEN120016 K121215 05/09/2014
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