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4560 Regulatory Class Class II Product Code OLO Dated August 8 2015 Received August 10 2015 Dear Mr. Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled sMisbranding by reference to premarket notifications 21CFR Part 807. Jonathan Reeves Principal Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale Florida 33317 September 16 2015 Re K142530 Trade/Device Name Partial Knee Application PKA Regulation Number 21 CFR 882. Page 1 of 5 Range...
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