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Wednesday, January 20, 2016 2:28:53 PM
The company must have more information than "ongoing..."
Difficult to believe they are unable to share additional details, what is the harm?
Again, if the company is willing to share "There is no reason we should not have approval by year end" then the same should eb applied to disclosing what the status is after more than 5-6 months, if indeed 510K was submitted when was stipulated as having been submitted.
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