Clearance Summary
BARRIER SAF-TE HYDROGEL DRAPE received FDA 510(k) clearance under submission number K922918, 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 1993-07-06.
- Submission: K922918
- Applicant / Sponsor: Johnson & Johnson International
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1993-07-06
Classification & Regulation
This clearance is catalogued under FDA product code KKX and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.