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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. 68 Southwoods Terrace SOUTHBURY CT 06488 VOF Re K170741 Trade/Device Name GTK Disposable Needle Guides 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...

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