CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) With Confocal Miniprobes

Confocal Optical Imaging

MAUNA KEA TECHNOLOGIES

The following data is part of a premarket notification filed by Mauna Kea Technologies with the FDA for Cystoflex Uhd R-c, Celioflex Uhd 5-c, Cellvizio 100 Series (800) With Confocal Miniprobes.

Pre-market Notification Details

Device IDK160416
510k NumberK160416
Device Name:CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) With Confocal Miniprobes
ClassificationConfocal Optical Imaging
Applicant MAUNA KEA TECHNOLOGIES 9, RUE D'ENGHIEN Paris,  FR 75010
ContactVeronique Dentan
CorrespondentMichael A. Daniel
DANIEL & DANIEL CONSULTING 340 JONES LANE Gardenville,  NV  89460
Product CodeOWN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-16
Decision Date2016-05-20
Summary:summary

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