Clearance Summary
MSI SURGI-GRADE UNIVERSAL TRACH TRAY received FDA 510(k) clearance under submission number K843561, sponsored by Medical Sterilization, 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 1984-10-24.
- Submission: K843561
- Applicant / Sponsor: Medical Sterilization, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1984-10-24
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.