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Tcsxyz

06/20/15 7:14 PM

#40204 RE: dsoulliere #40183

They also stated in a "SEC filing" they have a 430K asset of the building they were in......That was false, they were leasing it and have been evicted from said building

kheath39

06/20/15 7:21 PM

#40208 RE: dsoulliere #40183

WRONG. Its all in the wording my friend.

10Q from 11-14-13

On November 3, 2013, the Company filed a 510(k) Pre-Market Notification for FDA clearance of Yttrium-90 RadioGel TM Brackytherapy Product.

10Q from 5-15-15

In February 2014, the FDA determined that under Section 510(k) of the Act the Y-90 RadioGel™ device was not substantially equivalent to the devices cited by the Company, and concluded that the device is classified by statute as a Class III medical device, unless the device is reclassified. On December 23, 2014 the Company announced that it has submitted a de novo to the FDA for marketing clearance for its Y-90 RadioGel™ device pursuant to Section 513(f)(2) of the U.S. Food, Drug and Cosmetic Act (the “Act”).

They FILED the 510k but the ANNOUNCED they submitted de novo. No lies at all, just DECEPTION