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FDA 510(k) Application Details - K212322
Device Classification Name
More FDA Info for this Device
510(K) Number
K212322
Device Name
Cellvizio I.V.E. system with Confocal Miniprobes
Applicant
Mauna Kea Technologies
9 Rue d'Enghien
Paris 75010 FR
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Contact
Aline Criton
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Regulation Number
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Classification Product Code
OWN
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Date Received
07/26/2021
Decision Date
08/18/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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