Clearance Summary
AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418 received FDA 510(k) clearance under submission number K802965, sponsored by Associated Medical Products 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 1981-01-05.
- Submission: K802965
- Applicant / Sponsor: Associated Medical Products Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1981-01-05
Classification & Regulation
This clearance is catalogued under FDA product code FSM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.