Additional information was added to d9, h3, h4 and h6.H10: the device was received for evaluation.A visual inspection was performed which observed a hair inside the pouch.The reported condition was verified.The cause of the reported condition is manufacturing process related.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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