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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 Bontech Inc. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston Texas 77025 VOF Re K171485 Trade/Device Name...
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