我们检讨了你第510(k)项售前意向通知该装置市场的决心,并参照上述 耗电大幅度同等学历(适应症使用于附文)为合法销售始发州际装置 前五月28,1976商贸、颁布日期的医疗器械修正案 器件或已归类依照
英语翻译We have reviewed your Section 510(k) pre-market notifica
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