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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 external condom for anal intercourse or vaginal intercourse
De Novo Number DEN210034
Device Name ONE Male Condom
Requester
global protection corp.
12 channel st.
boston,  MA  02210
Contact davin wedel
Regulation Number884.5305
Classification Product Code
QRZ  
Date Received08/26/2021
Decision Date 02/23/2022
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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