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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. DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 April 24 2017 MindMaze SA John Beasley Senior Consultant Medtech Review LLC 257 Garnet Garden Street Henderson Nevada 89015 Re K162748 Trade/Device...
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Medtech Review LLC is a limited liability company that specializes in reviewing and evaluating medical technology products.
Any individual or entity that owns or operates Medtech Review LLC is required to file the necessary paperwork with the appropriate regulatory authorities.
To fill out Medtech Review LLC paperwork, one must include information about the company's ownership, management structure, financials, and any relevant medical technology products.
The purpose of Medtech Review LLC is to provide unbiased and thorough evaluations of medical technology products to help healthcare providers make informed decisions.
Information that must be reported on Medtech Review LLC includes company ownership details, financial information, and any conflicts of interest that may arise during product reviews.
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