FDA 510(k) Application Details - K122042

Device Classification Name	More FDA Info for this Device
510(K) Number	K122042
Device Name	CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
Applicant	MAUNA KEA TECHNOLOGIES 8 SNOWBERRY COURT ORINDA, CA 94563 US Other 510(k) Applications for this Company
Contact	MICHAEL DANIEL 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	07/12/2012
Decision Date	09/04/2012
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