FDA 510(k) Application Details - K203377

Device Classification Name	More FDA Info for this Device
510(K) Number	K203377
Device Name	VR101 Lubricating Intravaginal Ring
Applicant	J3 Bioscience, Inc. 825 North 300 West, Suite N231 Salt Lake City, UT 84103 US Other 510(k) Applications for this Company
Contact	R. Tyler McCabe Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2020
Decision Date	05/20/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review