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Re: GetRch$lwly post# 13402

Friday, 04/05/2024 11:24:32 AM

Friday, April 05, 2024 11:24:32 AM

Post# of 13776
Hey GR$. Nice article. However it was focused on a range (qfm/ qih) of products that have little in common with Hemostyp.
That being said it does shed a little light on timelines.
You should always read for what is real and not just what you want to interpret. Fake DR5 wouldn’t look for reality so he is a very poor reference. Like with all dr5 diagnosis you should always ask for a second opinion.

Here’s the articles concluding statement:

Conclusion

So there we have it - it takes on average between 154 (for QFM) to 201 (for QIH) total days to receive a 510(k) decision for SaMD products,