FDA 510(k) Application Details - K160797

Device Classification Name	More FDA Info for this Device
510(K) Number	K160797
Device Name	FMX314 Surgical Platform
Applicant	Fortimedix Surgical B.V. Daelderweg 20 Nuth 6361 HK NL Other 510(k) Applications for this Company
Contact	DIRKJAN BAKKER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2016
Decision Date	08/26/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review