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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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131 to 140 of 416 results
Decision Date To: 06/01/2024
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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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PROLONG ERGON MEDICAL LTD. DEN130047 03/20/2015
SpaceOAR System AUGMENIX , INC. DEN140030 04/01/2015
NOVA View Automated Fluorescense Microsc INOVA DIAGNOSTICS, INC. DEN140039 04/09/2015
COGNIVUE CEREBRAL ASSESSMENT SYSTEMS, INC DEN130033 06/05/2015
BRAINPORT V100 DEVICE WICAB, INC DEN130039 06/18/2015
ESOPHAGEAL COOLING DEVICE ADVANCED COOLING THERAPY, LLC DEN140018 06/23/2015
EarLens Contact Hearing Device EARLENS CORPORATION DEN150002 09/29/2015
FilmArray Meningitis/Encephalitis(ME) Pa BioFire Diagnostics, LLC DEN150013 10/08/2015
Sonablate 450 SonaCare Medical, LLC. DEN150011 10/09/2015
INVOcell INVO BIOSCIENCE DEN150008 11/02/2015
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