FDA 510(k) Application Details - K212049

Device Classification Name	Instrument, Ultrasonic Surgical   More FDA Info for this Device
510(K) Number	K212049
Device Name	Instrument, Ultrasonic Surgical
Applicant	TendoNova Corporation 3050 Business Park Drive, Suite A-2 Norcross, GA 30071 US Other 510(k) Applications for this Company
Contact	Mark Samuels 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	06/30/2021
Decision Date	03/08/2022
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