FDA 510(k) Application Details - K143447

Device Classification Name	More FDA Info for this Device
510(K) Number	K143447
Device Name	Dilapan-S
Applicant	Medicem Technology s.r.o. Karlovarska Trida 20 Kamenne Zehrovice 273 01 CZ Other 510(k) Applications for this Company
Contact	Adam Vlcek Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2014
Decision Date	04/17/2015
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