FDA 510(k) Application Details - K161882

Device Classification Name	Instrument, Ultrasonic Surgical   More FDA Info for this Device
510(K) Number	K161882
Device Name	Instrument, Ultrasonic Surgical
Applicant	INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE PLAINSBORO, NJ 08536 US Other 510(k) Applications for this Company
Contact	RESHAM RAMSAY 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	07/11/2016
Decision Date	10/14/2016
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