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Re: GetSeriousOK post# 80364

Thursday, 07/21/2016 3:54:59 PM

Thursday, July 21, 2016 3:54:59 PM

Post# of 352902
That makes no sense! There has to be a first of anything. Why can't ActiPatch be the predicate device (model) for all similar deices that follow? If the trials prove ActiPatch is safe, then the FDA should issue a clearance. Maybe this "predicate device" nonsense is just a straw man to foil.
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