Clearance Summary
TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET received FDA 510(k) clearance under submission number K121106, sponsored by Surgical Appliance Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-04-27.
- Submission: K121106
- Applicant / Sponsor: Surgical Appliance Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 2012-04-27
Classification & Regulation
This clearance is catalogued under FDA product code DWL and 21 CFR 880.5780, within the General Hospital review panel as a Class II device.