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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 K250561
Device Name Natural Cycles
Applicant
Natural Cycles Nordic AB
Sankt Eriksgatan 63 B
Stockholm,  SE 11234
Applicant Contact Megan Callanan
Correspondent
Natural Cycles Nordic AB
Sankt Eriksgatan 63 B
Stockholm,  SE 11234
Correspondent Contact Megan Callanan
Regulation Number884.5370
Classification Product Code
PYT  
Date Received02/25/2025
Decision Date 03/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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