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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. Ltd. C/O Mr. Leon Lu MEDevice Services LLC Director of Quality Regulatory Affairs 3500 South Dupont Highway Dover DE 19901 Re K133080 Trade/Device Name Plus Surgical Drapes EO Sterilized PMDB-XXX Regulation Number 21 CFR 878. DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New...

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