Clearance Summary
KELOCATE SHEETING received FDA 510(k) clearance under submission number K982051, sponsored by Allied Biomedical Corp.. 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 1998-08-05.
- Submission: K982051
- Applicant / Sponsor: Allied Biomedical Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 1998-08-05
Classification & Regulation
This clearance is catalogued under FDA product code MDA and 21 CFR 878.4025, within the General, Plastic Surgery review panel as a Class I device.