FDA 510(k) Application Details - K051436

Device Classification Name	More FDA Info for this Device
510(K) Number	K051436
Device Name	PRE' VAGINAL LUBRICANT
Applicant	INGFERTLITY, LLC 17206 S. SPANGLE CREEK ROAD VALLEYFORD, WA 99036 US Other 510(k) Applications for this Company
Contact	DENNIS CLIFTON 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	06/01/2005
Decision Date	10/13/2006
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