FDA 510(k) Application Details - K160677

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K160677
Device Name	Powered Laser Surgical Instrument
Applicant	MERIDIAN AG BIERIGUTSTRASSE 7 THUN CH-3608 CH Other 510(k) Applications for this Company
Contact	FRANZISKA GOTSCHI Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2016
Decision Date	05/19/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review