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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 March 17 2017 Noris Medical Ltd Simha Sibony VP Regulatory Science QA/RA 8 Hataasia Nesher 3688808 ISRAEL Re K162308 Trade/Device Name Noris Medical...
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