FDA 510(k) Application Details - K181367

Device Classification Name	Instrument, Ultrasonic Surgical   More FDA Info for this Device
510(K) Number	K181367
Device Name	Instrument, Ultrasonic Surgical
Applicant	Tenex Health, Inc. 26902 Vista Terrace Lake Forest,, CA 92630 US Other 510(k) Applications for this Company
Contact	David Vancelette 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	05/23/2018
Decision Date	08/28/2018
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