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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. 0V 0DULRQ 3HDW Director Ardgowan PM Ltd. 12/3 Grange Terrance Edinburgh Midlothian EH9 2LD UNITED KINGDOM March 19 2015 Re K142337 Trade/Device Name Blackford Analysis Registration Product Family Regulation Number 21 CFR 892. 2050 Regulatory Class II Product Code LLZ Dated February 10 2015 Received February 18 2015 Dear Ms....
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