FDA 510(k) Application Details - K153262

Device Classification Name	More FDA Info for this Device
510(K) Number	K153262
Device Name	PUREtraceÖ
Applicant	NEMO HEALTHCARE BV De Run 4630 5504 DB Veldhoven NL Other 510(k) Applications for this Company
Contact	Aron Wierts Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2015
Decision Date	02/07/2017
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