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Saturday, July 29, 2017 5:44:21 PM
I'm sticking with my original post , just looked over my notes
Cyrcadia has the 510k
Cyrcadia is expecting to be cleared for the FDA market entry
before the year is over
That is one of the value adds that will raise the price of Cyrcadia $2.50 -$5.00 also
Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer.
I pretend to know more than I do
Only a fool would actually believe anything I post.
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