FDA 510(k) Application Details - K982464

Device Classification Name	Instrument, Manual, Specialized Obstetric-Gynecologic   More FDA Info for this Device
510(K) Number	K982464
Device Name	Instrument, Manual, Specialized Obstetric-Gynecologic
Applicant	WOMEN FIRST HEALTHCARE, INC. 12220 EL CAMINO REAL, SUITE 400 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	JEANNE-MARIE VARGE Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	KNA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/1998
Decision Date	08/11/1998
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