FDA 510(k) Application Details - K983840

Device Classification Name	Electrocautery, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K983840
Device Name	Electrocautery, Gynecologic (And Accessories)
Applicant	WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. ORANGE, CT 06477 US Other 510(k) Applications for this Company
Contact	MICHAEL MALIS 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	10/30/1998
Decision Date	05/20/1999
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