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4oU. S. FOOD & DRUG ADMINISTRATION April 11, 2021, Custom fab, INC. % Laura Yard RAMA Consultant, Lean RAMA, LLC 12602 N Summer Wind Drive Marina, Arizona 85658Re: K203012 Trade/Device Name: Surgical
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US Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by regulating various products, including food, drugs, medical devices, tobacco, and more.
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Manufacturers, distributors, importers, and other entities involved in the production and distribution of food and drug products are required to file with the US Food and Drug Administration.
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To fill out US Food and Drug Administration forms, entities must provide detailed information about the products being produced or distributed, including ingredients, manufacturing processes, labeling, and more.
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The purpose of the US Food and Drug Administration is to ensure the safety and effectiveness of food, drugs, medical devices, cosmetics, and other products that are available to the public.
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Entities filing with the US Food and Drug Administration must report information about product ingredients, manufacturing processes, distribution practices, labeling, and more.
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