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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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21 to 30 of 416 results
Decision Date To: 05/29/2024
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Download Files | More About De Novo
Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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PneumoLiner ADVANCED SURGICAL CONCEPTS LTD. DEN150028 04/07/2016
ContainOR Advanced Surgical Concepts Ltd. DEN170075 12/19/2017
NIOX ARTICLE NO: 02-1000 AEROCRINE AB DEN030001 K021133 04/30/2003
AFFYMETRIX GENECHIP MICROARRAY INSTRUMEN Affymetrix, Inc. DEN040012 K042279 12/23/2004
CYTOSCAN(R) DX Affymetrix, Inc. DEN130018 K130313 01/17/2014
MAMMAPRINT AGENDIA BV DEN070009 K062694 02/06/2007
Parathyroid Detection (Model PTeye) Syst AiBiomed, Corp. DEN170056 11/02/2018
AeroForm Tissue Expander System AIRXPANDERS, INC DEN150055 12/21/2016
EndeavorRx Akili Interactive Labs Inc. DEN200026 06/15/2020
Kerasave AL.CHI.MI.A. S.r.l DEN200063 05/02/2022
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