Follow-up #2: date of submission 02/07/2017.Device evaluation: the device has been returned and evaluated by product analysis on 01/18/2017 with the following findings: a visual inspection of the cartridge was performed with no damage or defects noted.A fill test, and force test were performed and no failures were observed.Each cartridge lot is subjected to a statistical sampling plan and must pass testing for force (occlusion and loss of prime), cracks, and foreign material prior to release for distribution.
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