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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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61 to 70 of 416 results
Decision Date To: 06/12/2024
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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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Sonu Sound Health Systems, Inc. DEN230045 12/04/2023
Sonablate 450 SonaCare Medical, LLC. DEN150011 10/09/2015
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPH SOMNA THERAPEUTICS, LLC DEN130046 03/06/2015
cNEP Airway Sommetrics DEN140024 12/23/2015
SafeBreak Vascular Site Saver, Inc. d/b/a Lineus Medical DEN190043 05/27/2021
DECAPINOL ORAL RINSE SINCLAIR PHARMACEUTICALS LIMITED DEN050001 K041482 04/18/2005
eXciteOSA with remote and eXciteOSA with Signifier Medical Technologies DEN200018 02/05/2021
INNOVANCE VWF Ac Siemens Healthcare Diagnostics Products DEN200067 09/29/2022
ADVIA Centaur Enhanced Liver Fibrosis (E Siemens Healthcare Diagnostics Inc. DEN190056 08/20/2021
SYMPHONY DEVICE SENSORY MEDICAL, INC DEN110011 K102873 12/18/2013
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