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Mauna Kea Technologies Receives 510(K) Regulatory Clearance From FDA For Cellvizio In Urology



3/5/2014 6:34:53 AM

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Mauna Kea Technologies (Paris:MKEA) (Euronext: MKEA, FR0010609263), leader in the optical biopsy market, announced today it has obtained a 510(k) regulatory clearance from the U.S. Food & Drug Administration (FDA) for Cellvizio in the field of urology. The clearance covers the use of, Cellvizio's Uroflex™ B and CystoFlex™ F Confocal Miniprobes within anatomical tracts including but not limited to urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

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