Clearance Summary
TRICOTEX WOUND CONTACT LAYER DRESSING received FDA 510(k) clearance under submission number K864264, sponsored by Smith & Nephew, 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 1986-12-29.
- Submission: K864264
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4014
- Decision date: 1986-12-29
Classification & Regulation
This clearance is catalogued under FDA product code NAB and 21 CFR 878.4014, within the General, Plastic Surgery review panel as a Class I device.