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Re: GrandAdmiralThrawn post# 40896

Thursday, 07/03/2014 1:50:11 PM

Thursday, July 03, 2014 1:50:11 PM

Post# of 333228
No, dead wrong. That could be the soonest that we can expect the FDA to announce the new class has been established and 510k applications can be submitted. BIEL will then have to submit one and it could take anywhere from 6mo or more for it to either be approved or rejected. If it is approved that would finally mean the the "FDA approval" that so many on this board erroneously toss around has actually happened.