Vivos Inc (RDGL)

[kheath39]

Fresh and relevant my man. Still steaming.

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

GIVE US THE DE NOVO APP NUMBER