NLE

Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed

产品代码

NLE

器械名称

Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 874.4680

FDA 专业组

Ear, Nose, Throat

上市路径

需提交 510(k) 上市前通告

FDA 分类定义

Same as BWH except it is reprocessed. 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）。