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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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11 to 20 of 40 results
panel: Gastroenterology/Urology Decision Date To: 06/13/2024
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Device Name
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Requester
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De Novo
Number
sort by DeNovo number [0-9]
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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
Sonablate 450 SonaCare Medical, LLC. DEN150011 10/09/2015
RELIZORB ALCRESTA, INC. DEN150001 11/20/2015
WallFlex Biliary RX Fully Covered Stent BOSTON SCIENTIFIC DEN150040 06/03/2016
Sensor Monitored Alimentary Restriction SCIENTIFIC INTAKE DEN150033 09/26/2016
Embosphere Microspheres Biosphere Medical S.A. DEN160040 06/21/2017
Innovo Bio-Medical Research Ltd. DEN170049 11/06/2018
SEM Scanner (Model 200) Bruin Biometrics, LLC DEN170021 12/20/2018
Plenity Gelesis, Inc. DEN180060 04/12/2019
IB-Stim Innovative Health Solutions (IHS), Inc. DEN180057 06/07/2019
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