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fisherman2009

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fisherman2009

Re: IZZYBOY post# 5322

Tuesday, 09/22/2009 3:42:16 PM

Tuesday, September 22, 2009 3:42:16 PM

Post# of 330904
If they submit with a credible recommendation from a notable medical organization or physician the process will take much less time. With a recommendation included in the filing the FDA is required to respond within 30 days, otherwise without the recommendation they will have to wait 90 days for their class 2 device.
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