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Directory Results for IS 6IN TRACK.pub to IS 6SD3 LIFESHIELDTh VISIONTh Pre-Pierced Reseal Modification Special 610(k) Date: December 14, 2011 Section 6: JAN 1 22012 510(k) SUMMARY A summary of 510(k) safety and effectiveness ination in accordance with the requirements of 21 -