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ZetaReticuli

05/26/22 10:33 AM

#30749 RE: MouthBreather #30746

2021 was the submission. 2022 was a Re-submission of the 510k.

They had to resubmit the 510k because they failed two cytotoxicity tests which would have resulted in another rejection of the 510k. They told shareholders it was just a procedural issue with the test and they hired a toxicologist to correct the procedures and then failed the cytotoxicity test again. Then they blamed it on the lab and used a different lab to pass the test.