FDA 510(k) Application Details - K153422

Device Classification Name	Pessary, Vaginal   More FDA Info for this Device
510(K) Number	K153422
Device Name	Pessary, Vaginal
Applicant	Panpac Medical Corporation 6F-1,2, NO. 202, SEC.3 TA-TONG ROAD SHI-CHIH DISTRICT 22103 TW Other 510(k) Applications for this Company
Contact	YEN-MING PAN 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	11/25/2015
Decision Date	07/14/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review