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Re: bigred2010 post# 27939

Tuesday, 09/28/2010 1:30:58 PM

Tuesday, September 28, 2010 1:30:58 PM

Post# of 59551
so you feel a GAME CHANGER should be submitted through 510K?

i think that is the whole issue....the FDA does not


they want clinial trials and data collection

kimble