Clearance Summary
KELO-COTE SPRAY received FDA 510(k) clearance under submission number K053481, sponsored by Advanced Bio-Technologies, 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 2006-04-14.
- Submission: K053481
- Applicant / Sponsor: Advanced Bio-Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 2006-04-14
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.