MLT

Pelvic Exam Kit

产品代码: MLT
器械名称: Pelvic Exam Kit
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 884.4530
FDA 专业组: Obstetrics/Gynecology
上市路径: Enforcement Discretion
该代码近三年的 510(k): 1 件

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）。

FDA 官方分类页： MLT

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。