Vivos Inc (RDGL)

[Kooka_Duke]

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A 510 Clearance Is a Pre-Market Notification Of a Device That Has Been Already Classified As I II III & That's Being Marketed Right Now, Or Equivalent To That Device.....

As We All Know Here ADMD Is Looking For Class II Clearance For Their Device, Because They Already Tried For a 510 Clearance Back In Feb., And Was Rejected Because Their Device Wasn't ""EQUIVALENT"" To a Device That Is Already Being Marketed!!!......You'll Find That Excerpt Here:

In February 2014, the FDA rejected the Company's request for marketing clearance for the same device under Section 510(k) of the Act. The FDA determined that the device was not substantially equivalent, concluding that the device is classified by statute as a Class III medical device, unless the device is reclassified.

.....Once ADMD Gets FDA Clearance Their Device Will Be One Of a ""KIND""!!!!!!....,& Other Bio-Tech Companies Will Be Following US!!!!

Link:

http://isotopeworld.investorroom.com/2014-12-23-Advanced-Medical-Isotope-Corporation-Files-a-de-novo-Submission-for-Y-90-RadioGel-Device