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No risk of toxicity

We noted that the applicant stated that the nominated Axoguard HA+ Nerve Protector TM improved on the predicate device, but the applicant did not provide any additional information or evidence to support this claim

Kannt, A., and Rajagopal, S

The commenter stated that the creation of the new APC would ensure clinical and resource homogeneity and provide an opportunity in the future for similar services to be placed in the same APC

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