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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fertility Diagnostic, Contraceptive, Software Application
510(k) Number K241006
Device Name Natural Cycles
Applicant
Natural Cycles Nordic AB
St Eriksgatan 63b
Stockholm,  SE 112 34
Applicant Contact Megan Callanan
Correspondent
Natural Cycles Nordic AB
St Eriksgatan 63b
Stockholm,  SE 112 34
Correspondent Contact Megan Callanan
Regulation Number884.5370
Classification Product Code
PYT  
Date Received04/12/2024
Decision Date 07/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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