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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 K202897
Device Name Natural Cycles
Natural Cycles Nordic AB
St Eriksgatan 63b
Stockholm,  SE 112 34
Applicant Contact Raoul Scherwitzl
Heyer Regulatory Solutions LLC
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number884.5370
Classification Product Code
Date Received09/29/2020
Decision Date 06/24/2021
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