RemSleep Holdings Inc (RMSL): Well actually the 510k cannot take sever...

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Re: MouthBreather post# 30824

Tuesday, 05/31/2022 9:16:52 AM

Tuesday, May 31, 2022 9:16:52 AM

Well actually the 510k cannot take several years. There is a well defined process and RMSL got an extension on the Additional Information request. Had there not been a lab error the AI response would have been submitted back to FDA in January and final approval would have been completed already.

They are at the point of pass or fail… if fail they will need to submit a new 510k application

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