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Post# of 140538
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QuidWilson

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QuidWilson

Re: jjljr post# 94110

Wednesday, 08/28/2019 1:14:10 PM

Wednesday, August 28, 2019 1:14:10 PM

Post# of 140538
Do you know if this is class II or III? I'm assuming II since there's been no mention of PMA and all 510k - which means it's relatively LESS difficult since it's not a life sustaining device and you are basing your application a predicate device - which could only be Intuitive SP.
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