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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. Ashley M. Johnston Regulatory Affairs Specialist 7000 West William Cannon Drive Building One Austin Texas 78735 Re K161481 Trade/Device Name Ambient HipVac 50 Wand with Integrated Finger Switches Regulation Number 21 CFR 878. 4400 Regulatory Class Class II Product Code GEI Dated September 19 2016 Received September 20 2016...
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