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R. Wagner1, S. Beiden 1; G. Campbell2, C. Metz 3, Y. Jiang3, (1) CDRH FDA, Rockville, MD, US (2) OST, CDRH, Rockville, MD (3) University of Chicago, Chicago, IL
H.-P. Chan4,(1) OST, CDRH, Rockville, MD (2) OSB, CDRH, Rockville, MD; (3) Univ of Chicago, Chicago, IL; (4) Univ of Michigan, Ann Arbor, MI
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