FDA 510(k) Application Details - K111047

Device Classification Name	More FDA Info for this Device
510(K) Number	K111047
Device Name	CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
Applicant	MAUNA KEA TECHNOLOGIES INC. 660 NEWTOWN-YARDLEY RD. SUITE 107 NEWTON, PA 18940 US Other 510(k) Applications for this Company
Contact	CHRIS TIHANSKY 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	04/15/2011
Decision Date	08/08/2011
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	Y
Expedited Review