LWE

Bone Marrow Collection/Transfusion Kit

产品代码

LWE

器械名称

Bone Marrow Collection/Transfusion Kit

管理类别

第 2 类（Class II）

FDA 专业组

Unknown

上市路径

Enforcement Discretion

该代码近三年的 510(k)

3 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）。