LRR

First Aid Kit With Drug

产品代码

LRR

器械名称

First Aid Kit With Drug

管理类别

第 N 类（Not Classified）

FDA 专业组

Unknown

上市路径

Enforcement Discretion

该代码近三年的 510(k)

15 件

FDA 分类定义

Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - 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 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）。