FDA 510(k) Application Details - K182809

Device Classification Name	Instrument, Ultrasonic Surgical   More FDA Info for this Device
510(K) Number	K182809
Device Name	Instrument, Ultrasonic Surgical
Applicant	Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 US Other 510(k) Applications for this Company
Contact	MaryBeth Carson 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	10/03/2018
Decision Date	12/07/2018
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