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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 non-medicated topical formulation for treatment of erectile dysfunction.
De Novo Number DEN220078
Device Name Eroxon
Requester
futura medical developments limited
the surrey technology centre
40 occam road, surrey research park
guildford,  GB gu2 7yg
Contact rachael hawken
Regulation Number876.5021
Classification Product Code
QWW  
Date Received10/21/2022
Decision Date 06/09/2023
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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