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yaro1

07/29/17 11:50 AM

#24042 RE: change-for-a-buck #24041

Change,
its written clearly that they can sell in 2h 2017..if they didnt get the clearence how can they be so sure??

Btw thanks for the awsome info..
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change-for-a-buck

07/29/17 5:44 PM

#24062 RE: change-for-a-buck #24041

@Voo

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.