NLY

Microdebrider, Ent, High Speed, Single Use, Reprocessed

产品代码

NLY

器械名称

Microdebrider, Ent, High Speed, Single Use, Reprocessed

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 874.4140

FDA 专业组

Ear, Nose, Throat

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

1 件

FDA 分类定义

ENT microdebrider is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nost and throat surgery. These devices operate at high speed for precise tissue resection. (this is for reprocessed sing use ENT microdebrider.)

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）。