FDA 510(k) Application Details - K190323

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K190323
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	Desert Harvest, Inc 437 Dimmocks Mill Rd Suite 17b Hillsborough, NC 27278 US Other 510(k) Applications for this Company
Contact	Heather Florio Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	NUC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2019
Decision Date	09/25/2019
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