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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 K193416
Device Name Cellvizio I.V.E. with Confocal Miniprobes
Mauna Kea Technologies
9 Rue d'Enghien
paris,  FR 75010
Applicant Contact veronique dentan
Daniel & Daniel Consulting
340 Jones Lane
gardnerville,  NV  89460
Correspondent Contact michael a. daniel
Regulation Number876.1500
Classification Product Code
Subsequent Product Code
Date Received12/09/2019
Decision Date 02/28/2020
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 No