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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. 3080 Regulatory Class Class II Product Code ODP Dated January 5 2017 Received January 9 2017 Dear Dr. Allison Komiyama Part 807 labeling 21 CFR Part 801 medical device reporting reporting of medical devicerelated adverse events 21 CFR 803 good manufacturing practice requirements as set forth in the quality systems QS...
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