FDA 510(k) Application Details - K190872

Device Classification Name	More FDA Info for this Device
510(K) Number	K190872
Device Name	BioGenesis Fertility Lubricant
Applicant	Good Clean Love, Inc. 207 W. 5th Avenue Eugene, OR 97401 US Other 510(k) Applications for this Company
Contact	Wendy Strgar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2019
Decision Date	11/07/2019
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