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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. FORM FDA 3881 8/14 Page 1 of 1 PSC Publishing Services 301 443-6740 EF OPTIS METALLIC STENT OPTIMIZATION E.4 SW 510 k Summary Per 21 CFR 807. The OPTIS Metallic Stent Optimization E.4 SW software runs on 64-bit Microsoft Windows 7 Embedded Operating System only. PREDICATE DEVICE Predicate Device Lightlab Imaging Inc. OPTIS...
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