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Saturday, July 29, 2017 2:17:03 PM
Still it says: Cyrcadia, Inc. expects to apply for FDA Clearance and a CE Mark, (to market in the European Union and Asian markets), with anticipation of launching its technology to market possibly in late 2017 or early 2018.
I read this as they need this and CE for Asia and Europe: in the sheet "global launch sequence 2018" at Asia/Europe they state this:
CE/FDA Regulatory Process - Defined Time line to allow launch in FDA regulated countries H12018, CE countries H2 2018
At North America:
FDA Regulatory Clearance - Cyrcadia Predicate 510K Class II exists now - Sales can begin in US and other FDA guided countries H2 2017
still going for that Italian castle...????????
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