Clearance Summary
COMPRESSION LEGGING DEVICE received FDA 510(k) clearance under submission number K871889, sponsored by A-T Surgical Mfg. Co., 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 1987-08-04.
- Submission: K871889
- Applicant / Sponsor: A-T Surgical Mfg. Co., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 1987-08-04
Classification & Regulation
This clearance is catalogued under FDA product code LLK and 21 CFR 880.5780, within the General Hospital review panel as a Class II device.