Clearance Summary
Longterm NPWT Foam Dressing Kit received FDA 510(k) clearance under submission number K182458, sponsored by Zhejiang Longterm Medical Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-05-23.
- Submission: K182458
- Applicant / Sponsor: Zhejiang Longterm Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2019-05-23
Classification & Regulation
This clearance is catalogued under FDA product code OMP and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.