NLB

Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

产品代码

NLB

器械名称

Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 874.4420

FDA 专业组

Ear, Nose, Throat

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 分类定义

Same as KBG, KAB, and KCI but need one code for reprocessing. 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）。