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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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101 to 110 of 416 results
Decision Date To: 06/07/2024
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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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QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE D QUICK-MED TECHNOLOGIES, INC. DEN070002 K060662 02/25/2009
QuantX Quantitative Insights, Inc DEN170022 07/19/2017
ipsogen JAK2 RGQ PCR Kit QIAGEN INC DEN160028 03/27/2017
Q-Collar Q30 Sports Science, LLC DEN200017 02/26/2021
PROTEUS INGESTION CONFINMATION SYSTEMS PROTEUS BIOMEDICAL, INC. DEN120011 K113070 07/10/2012
Procise IFX ProciseDx Inc. DEN210056 09/29/2023
Procise ADL ProciseDx Inc. DEN220023 09/29/2023
AQUABEAM System PROCEPT BioRobotics Corporation DEN170024 12/21/2017
POMC/PCSK1/LEPR CDx Panel PreventionGenetics, LLC DEN200059 01/21/2022
CleanCisionTM Wound Retraction and Prote Prescient Surgical DEN150038 12/16/2016
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