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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K132389

CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED · Daniel & Daniel Consulting · decided 2014-02-25 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
UroFlex™B211-0142MAUNA KEA TECHNOLOGIESOWN03760187910130
UroFlex™B211-0142MAUNA KEA TECHNOLOGIESOWN00827002472730
CystoFlex™F211-0146MAUNA KEA TECHNOLOGIESOWN03760187910123
CystoFlex™F211-0146MAUNA KEA TECHNOLOGIESOWN00827002472747