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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 K120208
Device Name CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
Applicant
Mauna Kea Technologies
8 Snowberry Court
Orinda,  CA  94563
Applicant Contact MICHAEL A DANIEL
Correspondent
Mauna Kea Technologies
8 Snowberry Court
Orinda,  CA  94563
Correspondent Contact MICHAEL A DANIEL
Regulation Number876.1500
Classification Product Code
OWN  
Date Received01/24/2012
Decision Date 04/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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