K243576

RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port

510(k) 号: K243576
器械名称: RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
申请人: Smith & Nephew Medical, Ltd. GB
产品代码: OMP — Negative Pressure Wound Therapy Powered Suction Pump
批准日期: 2025-02-18
受理日期: 2024-11-19
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General, Plastic Surgery

也可从 FDA 官方下载： K243576.pdf

FDA 官方记录： K243576

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。