(b)(4).Mfg date: this lot was manufactured from february 23, 2015 to february 26, 2015.Evaluation summary: the device was received for evaluation.A visual inspection identified a white particle floating in the device.The origin of the particulate matter could not be determined.A capa has been opened to address this issue.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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