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The current regulatory impact analysis on SE reports indicates that whatever data are submitted, it should include test protocols, quantitative acceptance criteria, and test results as well as clearly identify when national or international standards are used to test the new and predicate products in addition to explaining any deviations from the standard or stating if no testing standards were used

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Lung Transplantation: Only curative option

Eldridge, A., Betson, T

This leads to slower tissue repair

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