{"product_id":"fda-510k-k240376","title":"FDA 510(k) K240376, Electroporation System (N3000), by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eLow Energy Direct Current Thermal Ablation System\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK240376\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Electroporation System (N3000)\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e878.44\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eOAB\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2024-02-07\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2024-10-04\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eGeneral \u0026amp; Plastic Surgery\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eGeneral \u0026amp; Plastic Surgery\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 5,127\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 3,555\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 1,572\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51309545488548,"sku":"FDA510K240376","price":3464.61,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k240376","provider":"FOIA Document Source","version":"1.0","type":"link"}