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Re: A deleted message

Wednesday, 06/02/2021 9:44:36 AM

Wednesday, June 02, 2021 9:44:36 AM

Post# of 31293
The way I read the PR, is that the 510k was probably submitted and FDA continue to have questions with the filing. This new company has probably reviewed the filing and has agreed to take over the continued filing process with the FDA.

Pretty sure they must be happy with what they see, as they would not want to risk their 100% success rate.
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