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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: 05/31/2024
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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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VIOGUARD SELF-SANITIZING KEYBOARD, MODEL VIOGUARD DEN100013 K092996 12/20/2011
Vibrant System Vibrant Ltd. DEN210052 08/26/2022
INFLOW INTRAURETHRAL VALVE-PUMP VESIFLO, INC. DEN130044 10/14/2014
OVA1 TEST VERMILLION DEN090004 K081754 09/11/2009
CINtec Histology (50 tests), CINtec Hist VENTANA MEDICAL SYSTEMS, INC DEN160019 03/04/2017
VENTANA anti-MLH-1(M1) Mouse Monoclonal Ventana Medical Systems DEN170030 10/27/2017
Sentosa SQ HIV Genotyping Assay Vela Diagnostics USA Inc BR190330 11/05/2019
Precision Flow® HVNI VAPOTHERM, INC. DEN170001 04/10/2018
UROSURGE PERCUTANEOUS SANS (STOLLER AFFE UROSURGE, INC. DEN000002 K992069 02/09/2000
EROS-CLITORAL THERAPY DEVICE (CTD) UROMETRICS, INC. DEN000006 K000280 04/28/2000
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