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Monday, August 23, 2010 12:50:13 AM
90% within 90 days 100% within 150 days decision issued...
Yes that's right. But that was only for 2010 510K. The FDA's overall statistics (shown on the FDA's website in the link I provided in my previous post) indicates that 98% of all 510K submissions are decided within 150 days. I certainly hope that we will have approval as soon as possible, but I don't want anybody to create a promise and hype which may not entirely be true.
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