Clearance Summary
MWI 400 WOUND DRESSING received FDA 510(k) clearance under submission number K874470, sponsored by Med-West, Inc.. 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 1987-12-18.
- Submission: K874470
- Applicant / Sponsor: Med-West, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4020
- Decision date: 1987-12-18
Classification & Regulation
This clearance is catalogued under FDA product code NAD and 21 CFR 878.4020, within the General, Plastic Surgery review panel as a Class I device.