FDA 510(k) Application Details - K043116

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K043116
Device Name	Media, Reproductive
Applicant	VITROLIFE SWEDEN AB FAKTORVAGEN 13 KUNGSBACKA SE-434 37 SE Other 510(k) Applications for this Company
Contact	MORGAN HUGOSSON Other 510(k) Applications for this Contact
Regulation Number	884.6180   More FDA Info for this Regulation Number
Classification Product Code	MQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2004
Decision Date	01/13/2005
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