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Re: Marnyen post# 4174

Wednesday, 10/14/2009 2:05:21 PM

Wednesday, October 14, 2009 2:05:21 PM

Post# of 59550
Hi Marnyen - I'm not sure but I don't think the pdufa applies to 510(k) applications. As to the date for approval, we were told the FDA has two weeks from the date of receipt (10/8) to provide a response. So I guess we should know something by the 22nd.