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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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121 to 130 of 416 results
Decision Date To: 06/16/2024
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Device Name
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De Novo
Number
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510(k)
Number
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Decision
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Procise ADL ProciseDx Inc. DEN220023 09/29/2023
PRINEO SKIN CLOSURE SYSTEM CLOSURE MEDICAL CORP. DEN090005 K082289 04/30/2010
PrimeStore MTM Longhorn Vaccines and Diagnostics LLC DEN170029 03/19/2018
PREVENA 125 and PREVENA PLUS 125 Therapy KCI USA, Inc. DEN180013 04/19/2019
Precision Flow® HVNI VAPOTHERM, INC. DEN170001 04/10/2018
PORTRAIT ANALYZER GREAT BASIN SCIENTIFIC DEN120013 K113358 04/30/2012
Portable Neuromodulation Stimulator (PoN Helius Medical, Inc. DEN200050 03/26/2021
POMC/PCSK1/LEPR CDx Panel PreventionGenetics, LLC DEN200059 01/21/2022
PneumoLiner ADVANCED SURGICAL CONCEPTS LTD. DEN150028 04/07/2016
PMD-200 Medasense Biometrics Ltd. DEN210022 02/17/2023
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