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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. Mr. Ray Kelly Consultant Licensale Inc. 57 Lazy Brook Rd. Monroe CT 03468 Re K160977 Trade/Device Name Toricolors hioxifilcon D Soft Contact Lenses Regulation Number 21 CFR 886. 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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