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IMGGorBust

06/16/10 10:53 PM

#18329 RE: Hopeful_IMGGer #18328

From the FDA's website:

Decision Letter Issued

The Document Mail Center staff will enter the final decision into the database and prepare the complete 510(k) file for electronic imaging. After completion of electronic imaging, and back-up microfilming, the original 510(k) files are destroyed.
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eagleagain2002

06/17/10 11:13 AM

#18356 RE: Hopeful_IMGGer #18328

Let's review...change in trading pattern + price increasing on low volume + calls between company and FDA indicating decision soon + April 23 + 60 days = June 22, decision day.