Grapefruit USA Inc (GPFT): Don't think De Novo would apply since th...

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Ryoko

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Ryoko

Re: BuyOnDips post# 26677

Tuesday, 09/14/2010 9:19:52 PM

Tuesday, September 14, 2010 9:19:52 PM

Don't think De Novo would apply since that's for expanding the use of an approved device. If IMGG get's nailed with an NSE, they'd likely be forced to go PMA which is not a disaster, but it would be annoying since it would mean additional delay to market.