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Re: dvice post# 30302

Friday, 10/29/2021 8:58:50 AM

Friday, October 29, 2021 8:58:50 AM

Post# of 31325
Yes the condensation test which is a new requirement due to the Phillips recall.

You stated 510k denied which is not the case, this application is still ongoing and I expect will not take long to get test done and device approved pending result of test.

Denied Implies they have to start 510k process all over again with a new submission, that is not the case.
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