FDA 510(k) Application Details - K221835

Device Classification Name	Instrument, Ultrasonic Surgical   More FDA Info for this Device
510(K) Number	K221835
Device Name	Instrument, Ultrasonic Surgical
Applicant	Integra Lifesciences Corporation 1100 Campus Road Princeton, NJ 08540 US Other 510(k) Applications for this Company
Contact	Alexandra Wells 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	06/23/2022
Decision Date	08/22/2022
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