{"id":12217,"date":"2018-12-12T16:37:22","date_gmt":"2018-12-12T15:37:22","guid":{"rendered":"https:\/\/isocele-medical.com\/nos-prestations\/strategie-reglementaire\/dossiers-510k-pour-les-usa\/"},"modified":"2026-07-24T10:21:45","modified_gmt":"2026-07-24T08:21:45","slug":"510k-applications-for-the-usa","status":"publish","type":"page","link":"https:\/\/isocele-medical.dev.serv5.tribu-and-co.com\/en\/our-services\/regulatory-compliance\/510k-applications-for-the-usa\/","title":{"rendered":"510(k) FDA (U.S.)"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"<p class=\"PDq2pG_selectionAnchorContainer\" data-start=\"233\" data-end=\"391\">The 510(k) application, also known as Premarket Notification, is one of the main pathways to the U.S. market for medical devices.<\/p>\n<p data-start=\"914\" data-end=\"1158\">Isoc\u00e8le Conseil assists medical device manufacturers in defining their U.S. regulatory strategy, identifying a predicate device, compiling the 510(k) 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