Replies to post #28642 on RemSleep Holdings Inc (RMSL)

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The problem is there were at least 100 days from November 2019 press release to the COVID pandemic. This thing was packaged in boxes?

Look at the timeline for 510(K) application process:

Day 1: FDA receives 510(K) submission

By Day 7: FDA sends Acknowledgement Letter OR FDA sends Hold Letter

By Day 15: FDA conducts Acceptance Review

By Day 60: FDA conducts Substantive Review

By Day 90: FDA sends final MDUFA Decision on 510(K)

By Day 100: If MDUFA is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues