FDA 510(k) Application Details - K192963

Device Classification Name	Instrument, Ultrasonic Surgical   More FDA Info for this Device
510(K) Number	K192963
Device Name	Instrument, Ultrasonic Surgical
Applicant	Katalyst Surgical, LLC 754 Goddard Avenue Chesterfield, MO 63005 US Other 510(k) Applications for this Company
Contact	Meryl Koch Wilhelm 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	10/23/2019
Decision Date	06/19/2020
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