Bluesky why do you think that approval is only a few weeks away. The way I read the announcement on MEBsleep (501K) is that the clarifications they are receiving from FDA are a preface only to allow FDA to "start" their review of the submission. Doesn't that process take 6-9 months once it starts?
What am I missing here?
Bluesky why do you think that approval is only a few weeks away....
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