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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 May 25 2017 L Z US Inc. Jenella Coutts MPH Director of Regulatory Affairs 6 Horizon Road Fort Lee New Jersey 07024 Re K170486 Trade/Device Name...
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