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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 K183640
Device Name Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
Applicant
Mauna Kea Technologies
9 Rue D'Enghien
Paris,  FR 75010
Applicant Contact Veronique Dentan
Correspondent
Daniel & Daniel Consulting
340 Jones Lane
Gerdnerville,  NV  89460
Correspondent Contact Michael A. Daniel
Regulation Number876.1500
Classification Product Code
OWN  
Subsequent Product Code
GCJ  
Date Received12/26/2018
Decision Date 02/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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