FDA 510(k) Application Details - K982739

Device Classification Name	Electrocautery, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K982739
Device Name	Electrocautery, Gynecologic (And Accessories)
Applicant	GYNEX CORP. 200 GREGORY LANE, SUITE C-100 PLEASANT HILL, CA 94523-3389 US Other 510(k) Applications for this Company
Contact	DAVID W SCHLERF Other 510(k) Applications for this Contact
Regulation Number	884.4120   More FDA Info for this Regulation Number
Classification Product Code	HGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/1998
Decision Date	03/12/1999
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