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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
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
Applicant Contact CHRIS TIHANSKY
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact MICHAEL S OGUNLEYE
Regulation Number876.1500
Classification Product Code
OWN  
Date Received04/15/2011
Decision Date 08/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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