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Re: MASTER P post# 53632

Thursday, 01/28/2016 9:15:48 PM

Thursday, January 28, 2016 9:15:48 PM

Post# of 178139
"Nor do we believe your device is of low to moderate risk and thus eligible for denovo " --fda denial

Fda said in the denail denovo not the correct pathway. Can post or email denial letter
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