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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 K193330
Device Name Clue Birth Control
Applicant
Biowink GmbH
Adalbertstrasse 7-8
Berlin,  DE 10999
Applicant Contact Carrie Walter
Correspondent
Biowink GmbH
One Embarcadero Center, 30th Floor
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number884.5370
Classification Product Code
PYT  
Date Received12/02/2019
Decision Date 02/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Clinical Trials NCT02833922
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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