The device was received for evaluation.Visual inspection was performed and particulate matter was identified in the device.Inspection under a microscope was conducted and the loose particulate matter was determined to be fibers; however, the size of the identified fibers was within specification for this product.The sample was found to be within 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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