Clearance Summary
SINGLE USE INSTRUMENT TRAY received FDA 510(k) clearance under submission number K951149, sponsored by Medcare Custom Packaging, 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 1995-04-06.
- Submission: K951149
- Applicant / Sponsor: Medcare Custom Packaging, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1995-04-06
Classification & Regulation
This clearance is catalogued under FDA product code LRO and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.