NNG

Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed

产品代码

NNG

器械名称

Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 876.5820

FDA 专业组

Gastroenterology, Urology

上市路径

需提交 510(k) 上市前通告

FDA 分类定义

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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）。