FDA 510(k) Application Details - K170797

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K170797
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	Wettrust Korea Co., Ltd. 312 The Prau, 27 Jeongjail-ro, Bundang-gu Seongnam 463-480 KR Other 510(k) Applications for this Company
Contact	Sungho Lee 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	03/17/2017
Decision Date	12/06/2017
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