FCD

Barium Enema Kit

产品代码

FCD

器械名称

Barium Enema Kit

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 876.5210

FDA 专业组

Gastroenterology, Urology

上市路径

豁免 510(k)（仍须遵守通用控制与注册列名）

该代码近三年的 510(k)

2 件

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 www.fda.gov/cdrh/ode/convkit.html. 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）。