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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. Chris Henza Director Regulatory and Operations Regulatory Compliance Associates Inc. 10411 Corporate Drive Suite 102 Pleasant Prairie WI 53158 Re K151554 Trade/Device Name Occlusion Perfusion Catheter Regulation Number 21 CFR 870. It is not indicated for use in the neurovasculature. Type of Use Select one or both as...
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