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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 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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Eroxon Futura Medical Developments Limited DEN220078 06/09/2023
Plenity Gelesis, Inc. DEN180060 04/12/2019
GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD. DEN010002 K010312 08/01/2001
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY GIVEN IMAGING LTD. DEN120023 K123666 01/29/2014
IB-Stim Innovative Health Solutions (IHS), Inc. DEN180057 06/07/2019
EndoRotor Device Interscope, Inc DEN200016 12/23/2020
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. DEN000008 K001447 02/16/2001
Parallel Mahana Therapeutics, Inc. DEN200029 11/25/2020
DuraGraft Marizyme, Inc. DEN230002 10/04/2023
iTind System Medi-Tate Ltd. DEN190020 02/25/2020
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