Clearance Summary
INTRASITE CAVITY WOUND DRESSING received FDA 510(k) clearance under submission number K895354, 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 1989-11-07.
- Submission: K895354
- 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: 1989-11-07
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.