FDA 510(k) Application Details - K151593

Device Classification Name	More FDA Info for this Device
510(K) Number	K151593
Device Name	Cellvizio 100 Series System with Confocal Miniprobes
Applicant	MAUNA KEA TECHNOLOGIES 9 RUE D'ENGHIEN PARIS 75010 FR Other 510(k) Applications for this Company
Contact	SOPHIE REHAULT 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	06/12/2015
Decision Date	10/23/2015
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