(b)(4).This lot was manufactured from october 31, 2013 to november 1, 2013.Evaluation summary: the sample was received for evaluation.A visual inspection was performed with no issues noted.Functional flow testing was performed and the device was found to flow normally without leaks or backflow occurring.No malfunctions or abnormalities were identified during evaluation.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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