NKY

Blade, Keratome, Reprocessed

产品代码

NKY

器械名称

Blade, Keratome, Reprocessed

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 886.4370

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

Blade for keratome to make flap in cornea for LASIK refractive surgery. Same as previously cleared blade for keratomes, product codes HMY and HNO, except this 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）。