Clearance Summary
THE ON-GARD CORD-CADDY received FDA 510(k) clearance under submission number K903855, sponsored by On-Gard Systems, 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 1990-09-07.
- Submission: K903855
- Applicant / Sponsor: On-Gard Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1990-09-07
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.