OJK

Eye Tray

产品代码: OJK
器械名称: Eye Tray
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 886.4790
FDA 专业组: Ophthalmic
上市路径: 豁免 510(k)（仍须遵守通用控制与注册列名）

FDA 分类定义

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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）。

FDA 官方分类页： OJK

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。