Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact