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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. 8MP MDNC-6121 Regulation Number 21 CFR 892. 2050 Regulatory Class II Product Code PGY Dated March 9 2017 Received March 13 2017 Dear Ms. 0V HOHQD 6RHQHQ Regulatory Affairs Officer President Kennedypark 35 Kortrijk 8500 BELGIUM March 28 2017 Re K170476 Trade/Device Name Nio Color 5. It is specially designed for breast...
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