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DreDiZzlE

02/02/16 11:43 AM

#53857 RE: Popeye #53856

I wont say you're wrong that radiogel could be revolutionary. But it should be a "revolutionary" product going through class 3 PMA not denovo.

Fda.gov lists class 2 examples as : wheelchairs, condoms, pregnancy tests kits.

Fda.gov says examples of class 3 is: "injectable and sustains life ".

It doesn't take a radiologist to see what classification it fits in.

Now in your opinion is radiogel closer to a pregnancy test kit or something injectable that sustains life?