FDA 510(k) Application Details - K160416

Device Classification Name	More FDA Info for this Device
510(K) Number	K160416
Device Name	CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
Applicant	MAUNA KEA TECHNOLOGIES 9, RUE D'ENGHIEN PARIS 75010 FR Other 510(k) Applications for this Company
Contact	VERONIQUE DENTAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2016
Decision Date	05/20/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review