FDA 510(k) Application Details - K980237

Device Classification Name	Instrument, Manual, Specialized Obstetric-Gynecologic   More FDA Info for this Device
510(K) Number	K980237
Device Name	Instrument, Manual, Specialized Obstetric-Gynecologic
Applicant	GYNEX CORP. 1000 BURNETT AVE. SUITE 450 CONCORD, CA 94520 US Other 510(k) Applications for this Company
Contact	DAVID W SCHLERF 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	01/23/1998
Decision Date	04/08/1998
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