Clearance Summary
MEDSURG MARSHMALLOW TRAY received FDA 510(k) clearance under submission number K920421, sponsored by Medsurg Industries, 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 1993-12-13.
- Submission: K920421
- Applicant / Sponsor: Medsurg Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5000
- Decision date: 1993-12-13
Classification & Regulation
This clearance is catalogued under FDA product code GAT and 21 CFR 878.5000, within the General, Plastic Surgery review panel as a Class II device.