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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 K191144
Device Name Cellvizio 100 Series System with Confocal Miniprobes
Applicant
Mauna Kea Technologies
9, Rue d'Enghien
Paris,  FR 75010
Applicant Contact Veronique Dentan
Correspondent
Daniel & Daniel Consulting
340 Jones Lane
Gardnerville,  NV  89460
Correspondent Contact Michael A. Daniel
Regulation Number876.1500
Classification Product Code
OWN  
Subsequent Product Codes
GCJ   GWG  
Date Received04/30/2019
Decision Date 01/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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