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QuidWilson

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QuidWilson

Re: BigT82 post# 64577

Thursday, 12/28/2017 3:50:44 PM

Thursday, December 28, 2017 3:50:44 PM

Post# of 140471
If this is a class II device with a 510k submission and not PMA, it's claimed to be substantially equivalent to a predicate device, an should not require live human testing pre market. Someone double check me but that's my understanding.
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