FDA 510(k) Application Details - K032969

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K032969
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	HELICA INSTRUMENTS, LTD 1020 WEST BAY AVE. NEWPORT BEACH, CA 92661 US Other 510(k) Applications for this Company
Contact	JOHN B WEBB Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	GEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2003
Decision Date	02/04/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review