Clearance Summary
BIOCLUSIVE(R) ABSORBENT DRESSING received FDA 510(k) clearance under submission number K896828, sponsored by Johnson & Johnson International. 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 1990-11-21.
- Submission: K896828
- Applicant / Sponsor: Johnson & Johnson International
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4018
- Decision date: 1990-11-21
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.