FDA 510(k) Application Details - K081459

Device Classification Name	Instrument, Ultrasonic Surgical   More FDA Info for this Device
510(K) Number	K081459
Device Name	Instrument, Ultrasonic Surgical
Applicant	INTEGRA RADIONICS, INC. 22 TERRY AVENUE BURLINGTON, MA 01803 US Other 510(k) Applications for this Company
Contact	KEVIN J O'CONNELL Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LFL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2008
Decision Date	08/13/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review