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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. Director Regulatory Affairs 1430 Decision Street Vista California 92081 Re K170918 Trade/Device Name Compex Sport Elite Regulation Number 21 CFR 890. DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002...

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