FDA 510(k) Application Details - K193330

Device Classification Name	More FDA Info for this Device
510(K) Number	K193330
Device Name	Clue Birth Control
Applicant	BioWink GmbH Adalbertstrasse 7-8 Berlin 10999 DE Other 510(k) Applications for this Company
Contact	Carrie Walter Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2019
Decision Date	02/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review