PYK

Venous Ulcer Kit

产品代码

PYK

器械名称

Venous Ulcer Kit

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 878.4014

FDA 专业组

General, Plastic Surgery

上市路径

Enforcement Discretion

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）。