FDA 510(k) Application Details - K130273

Device Classification Name	Dilator, Vaginal   More FDA Info for this Device
510(K) Number	K130273
Device Name	Dilator, Vaginal
Applicant	Panpac Medical Corporation 6F-1, 2 NO. 202, SEC 3 TA-TONG ROAD SHI-CHIH DISTRICT, NEW TAIPEI CITY 22103 TW Other 510(k) Applications for this Company
Contact	Yen-Ming Pan Other 510(k) Applications for this Contact
Regulation Number	884.3900   More FDA Info for this Regulation Number
Classification Product Code	HDX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2013
Decision Date	08/08/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review