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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 device, fertility diagnostic, contraceptive, software application
De Novo Number DEN170052
Device Name Natural Cycles
Natural Cycles Nordic AB
luntmakargatan 26
stockholm,  SE 111-37
Contact raoul scherwitzl
Regulation Number884.5370
Classification Product Code
Date Received09/20/2017
Decision Date 08/10/2018
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE