Additional information was received for h3, h4, h6, and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photo sample did not identify any abnormalities that could have contributed to the reported condition.Due to the nature of the sample, no additional testing could be performed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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