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With respect to the newness criterion at 419.66(b)(1), FDA granted the applicant 510(k) clearance for the Axoguard HA+ Nerve Protector TM on April 7, 2023, and then granted a second 510(k) clearance for an expanded indication on October 12, 2023

In plain English, this means it mimics two different hormones naturally produced by your body

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2021;13(11):e19924

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The consumption of fresh produce irrigated with contaminated water poses a severe risk for infectious disease outbreaks, both through direct exposure and cross-contamination