MAC

Decontamination Kit

产品代码

MAC

器械名称

Decontamination Kit

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 878.4014

FDA 专业组

General, Plastic Surgery

上市路径

Enforcement Discretion

FDA 历史累计 510(k)

2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。