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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 K212322
Device Name Cellvizio I.V.E. system with Confocal Miniprobes
Mauna Kea Technologies
9 Rue d'Enghien
Paris,  FR 75010
Applicant Contact Aline Criton
Daniel & Daniel Consulting
340 Jones Lane
Gardnerville,  NV  89460
Correspondent Contact Michael A. Daniel
Regulation Number876.1500
Classification Product Code
Subsequent Product Code
Date Received07/26/2021
Decision Date 08/18/2021
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 Yes