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V. 0U -XUMHQ HLVWUD Business Unit Manager Theraview Klepelhoek 11 3833 GZ Leusden THE NETHERLANDS March 3 2017 Re K170058 Trade/Device Name TheraView TBI Imager Regulation Number 21 CFR 892. Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. 97. For questions regarding the reporting of adverse events under the MDR regulation 21 CFR Part 803 please go to of Surveillance and...
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