Clue Birth Control

Device, Fertility Diagnostic, Contraceptive, Software Application

BioWink GmbH

The following data is part of a premarket notification filed by Biowink Gmbh with the FDA for Clue Birth Control.

Pre-market Notification Details

Device IDK193330
510k NumberK193330
Device Name:Clue Birth Control
ClassificationDevice, Fertility Diagnostic, Contraceptive, Software Application
Applicant BioWink GmbH Adalbertstrasse 7-8 Berlin,  DE 10999
ContactGeorgina Denis
CorrespondentYarmela Pavlovic
BioWink GmbH One Embarcadero Center 30th Floor San Francisco,  CA  94111
Product CodePYT  
CFR Regulation Number884.5370 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-02
Decision Date2021-02-18

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