Clearance Summary
DESERET OFFSET PRN ADAPTER received FDA 510(k) clearance under submission number K821245, sponsored by Warner-Lambert Co.. 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 1982-05-13.
- Submission: K821245
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1982-05-13
Classification & Regulation
This clearance is catalogued under FDA product code KGZ and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.