FDA 510(k) Application Details - K984172

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K984172
Device Name	Media, Reproductive
Applicant	NIDACON INTERNATIONAL AB P.O. BOX 7007 DEERFIELD, IL 60015 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM 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	11/20/1998
Decision Date	01/14/1999
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