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boston745

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Re: hondobud post# 7479

Saturday, 11/26/2016 4:35:58 PM

Saturday, November 26, 2016 4:35:58 PM

Post# of 41637
What they should have done was file a De Novo before submission and pushed CsC through as a new product instead of using graft as predicate. CsC not a Class III device but De Novo would have determined that.
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