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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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191 to 200 of 412 results
Decision Date To: 05/03/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
Date
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reSet PEAR THERAPEUTICS, INC. DEN160018 09/14/2017
VENTANA anti-MLH-1(M1) Mouse Monoclonal Ventana Medical Systems DEN170030 10/27/2017
NSS-2 System Innovative Health Solutions (IHS), Inc. DEN170018 11/15/2017
MSK-IMPACT (Integrated Mutation Profilin Memorial Sloan-Kettering Cancer Center DEN170058 11/15/2017
FilmArray Respiratory Panel 2 plus (RP2p BioFire Diagnostics, LLC DEN170017 11/24/2017
GeneSTAT.MDx Coccidioides Assay DxNA, LLC DEN170041 11/29/2017
ContainOR Advanced Surgical Concepts Ltd. DEN170075 12/19/2017
IlluminOss Bone Stabilization System IllminOss Medical, Inc. DEN160062 12/19/2017
AQUABEAM System PROCEPT BioRobotics Corporation DEN170024 12/21/2017
remOVE System OVESCO ENDOSCOPY AG DEN160014 12/22/2017
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