K232046

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection

510(k) 号: K232046
器械名称: Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
申请人: Xeridiem Medical Devices, A Spectrum Plastics Group Company AZ · US
产品代码: PIF — Gastrointestinal Tubes With Enteral Specific Connect
批准日期: 2023-10-06
受理日期: 2023-07-10
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Gastroenterology, Urology

也可从 FDA 官方下载： K232046.pdf

FDA 官方记录： K232046

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。