PAD

Chest Drainage Kit

产品代码

PAD

器械名称

Chest Drainage Kit

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 880.6740

FDA 专业组

General Hospital

上市路径

Enforcement Discretion

标记

豁免 GMP（质量体系）

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 www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

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）。