K262427

Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)

510(k) 号: K262427
器械名称: Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)
申请人: Hh Global Technology, Inc. GA · US
产品代码: FMI — Needle, Hypodermic, Single Lumen
批准日期: 2026-08-10
受理日期: 2026-07-16
决定: Substantially Equivalent
审查途径: Special
咨询委员会: General Hospital

PDF下载 510(k) Summary本站存档 · 0.4 MB · FDA 公有领域文件

也可从 FDA 官方下载： K262427.pdf

FDA 官方记录： K262427

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。