Clearance Summary
INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) received FDA 510(k) clearance under submission number K901876, sponsored by Smith & Nephew United, 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 1990-06-28.
- Submission: K901876
- Applicant / Sponsor: Smith & Nephew United, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4018
- Decision date: 1990-06-28
Classification & Regulation
This clearance is catalogued under FDA product code KOZ and 21 CFR 878.4018, within the General, Plastic Surgery review panel as a Class I device.