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5.3 510(k) Summary Statement American Medical Systems (AMS) 10700 Been Road West Minnetonka, MN 55343 Mona Unman Phone: 952.930.6204 Fax: 952.930.5785 Surgical Mesh AMS Elevate Tm Anterior and Apical
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Who needs FDA 3654:

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Manufacturers: FDA 3654 is typically required for manufacturers engaged in the production, packaging, labeling, or holding of food, drugs, medical devices, cosmetics, and other FDA-regulated products.
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Importers: Importers of FDA-regulated products are also typically required to fill out FDA 3654. This is necessary to ensure compliance with applicable regulations for imported goods.
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In summary, filling out FDA 3654 requires careful attention to detail, adherence to instructions, and providing accurate and complete information. It is typically needed by manufacturers, importers, distributors, and government agencies involved in the production, importation, distribution, and regulation of FDA-regulated products.
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