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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. 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 SOPRO - Acteon Group 0U 5LFN 5RVDWL Quality Manager Satelec Acteon Group 124 Gaither Drive Suite 140 MOUNT LAUREL NJ 08054 August 17 2015 Re K142995...
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