Additional information: the device was received for evaluation.Visual inspection noted a loose particulate matter present on the outside wall of the inner pouch.Microscopic examination determined the particulate matter was a fiber less than 0.80 mm squared.The reported condition was verified; however, as the particulate matter is less than 0.80 mm squared the product meets specification.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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