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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. HOO Consultant Licensale Inc 57 Lazy Brook Road MONROE CT 06468 October 14 2016 Re K162011 Trade/Device Name MedDream Regulation Number 21 CFR 892. 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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