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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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181 to 190 of 412 results
Decision Date To: 04/25/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
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INFLOW INTRAURETHRAL VALVE-PUMP VESIFLO, INC. DEN130044 10/14/2014
INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REA CENTERS FOR DISEASE CONTROL AND PREVENTI DEN060008 K060159 02/03/2006
INFRASCANNER, MODEL 1000 INFRASCAN, INC. DEN100002 K080377 12/13/2011
INNOVANCE VWF Ac Siemens Healthcare Diagnostics Products DEN200067 09/29/2022
Innovo Bio-Medical Research Ltd. DEN170049 11/06/2018
INRANGE REMOTE MEDICATION MANAGEMENT SYS INRANGE SYSTEMS, INC. DEN060002 K051338 06/13/2007
InSpace Subacromial Tissue Spacer System Ortho-Space Ltd. DEN200039 07/12/2021
INTROL CF PANEL I CONTROL MAINE MOLECULAR QUALITY CONTROLS, INC. DEN060007 K060070 10/12/2006
Invitae Common Hereditary Cancers Panel Invitae Corporation DEN210011 09/29/2023
INVOcell INVO BIOSCIENCE DEN150008 11/02/2015
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