NLA

Knife, Ophthalmic, Reprocessed

产品代码

NLA

器械名称

Knife, Ophthalmic, Reprocessed

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 886.4350

FDA 专业组

Ophthalmic

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

Used for cutting soft tissue in or around the eye. Surgical knife same as product code HNN, except this one 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）。