1.510(k)编写技巧2.医疗器械的变更和特殊510(k)3.第三方审核项目 510(k)编写技巧 •介绍•报告基本原则•报告内容要求 介绍 A510(k)isapremarketingsubmissionmadetoFDAtodemonstratethatthedevicetobemarketedisassafeandeffective,thatis,substantiallyequivalent(SE),toalegallymarketeddevicethatisnotsubjecttopremarket...
(Piston Syringe) 监管类别(Regulatory Class):II 类(Class II) 产品编码(Product Code):FMF, FMI 二、对公司的影响 公司自毁式注射器产品通过美国 FDA 510(K)的审核,标志着康康医疗生产的一次性使用无菌自毁式注射器获得了美国市场准入资格,有利于进一步增加公司产品开拓国际市场的综合竞争力,对公司未来的经营将...
产品型号 一份报告中可同时递交的型号类型 活塞式注射器 Product Code: FMF 型号类型型号类型::22 ml,ml, 55 ml,ml, 1010 ml,ml, 3030 ml,ml, 5050 mlml 一份报告中不可同时递交的型号类型 PE医用检查手套 Product Code: LZA 型号类型:有粉, 无粉 Shanghai MIDLINK Business Consulting Co., Ltd. 5 ...
FDA法规讲座之510(K)文件编写 1.510(k)编写技巧2.医疗器械的变更和特殊510(k)3.第三方审核项目 上海佐策信息科技有限公司 510(k)编写技巧 ?介绍?报告基本原则?报告内容要求 上海佐策信息科技有限公司 介绍 A510(k)isapremarketingsubmissionmadetoFDAtodemonstratethatthedevicetobemarketedisassafeandeffective,thatis,...
Colchicine is a near-200 year-old drug FDA approved NDAs for in July 2009 for Mutual and AR (here and here) for the treatment of gout flares (NDA No. 22-351, for which FDA granted 3-year exclusivity) and for the treatment of Familial Mediterranean Fever (“FMF”) (NDA No. 22-352...
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Product Actions Automate any workflow Security Find and fix vulnerabilities Codespaces Instant dev environments GitHub Copilot Write better code with AI Code review Manage code changes Issues Plan and track work Discussions Collaborate outside of code Explore All features Documentation GitHub...
FDA法规讲座之510(K)编写 FDA法规讲座之510(K)文件编写 1.510(k)编写技巧2.医疗器械的变更和特殊510(k)3.第三方审核项目 510(k)编写技巧 •介绍•报告基本原则•报告内容要求 上海佐策信息科技有限公司 介绍 A510(k)isapremarketingsubmissionmadetoFDAtodemonstratethatthedevicetobemarketedisassafeandeffective,...
FDA法规讲座之510(K)文件编写 1.510(k)编写技巧2.医疗器械的变更和特殊510(k)3.第三方审核项目 上海佐策信息科技有限公司 510(k)编写技巧 ?介绍?报告基本原则?报告内容要求 上海佐策信息科技有限公司 介绍 A510(k)isapremarketingsubmissionmadetoFDAtodemonstratethatthedevicetobemarketedisassafeandeffective,thatis,...