FDA 510(k) Application Details - K132313

Device Classification Name	Pessary, Vaginal   More FDA Info for this Device
510(K) Number	K132313
Device Name	Pessary, Vaginal
Applicant	EIS CORPORATION #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, Seoul 135-768 KR Other 510(k) Applications for this Company
Contact	YANG HO DONG Other 510(k) Applications for this Contact
Regulation Number	884.3575   More FDA Info for this Regulation Number
Classification Product Code	HHW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2013
Decision Date	12/05/2014
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