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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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Device Classification Name temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia
De Novo Number DEN190020
Device Name iTind System
Requester
Medi-Tate Ltd.
14 hailan street
or akiva,  IL 3060000
Contact lihi liviatan
Regulation Number876.5510
Classification Product Code
QKA  
Date Received04/02/2019
Decision Date 02/25/2020
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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