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Zaffer Syed Senior Director Clinical Development Strategic Marketing OrthoAccel Technologies Inc. 6575 West Loop South Suite 200 Bellaire Texas 77401 Re K153048 Trade/Device Name AcceleDent Aura Regulation Number 21 CFR 872. Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled sMisbranding by reference to premarket notifications 21CFR Part 807. Our modified AcceleDent Aura has the same intended use as the identified predicate devices it has...
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