FDA 510(k) Application Details - K963348

Device Classification Name	Electrocautery, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K963348
Device Name	Electrocautery, Gynecologic (And Accessories)
Applicant	WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. MILFORD, CT 06460 US Other 510(k) Applications for this Company
Contact	RAYMOND A WILEY 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	08/26/1996
Decision Date	03/19/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review