Clearance Summary
HEAD-UP SUPINE SAFETY SUPPORT CUSHION received FDA 510(k) clearance under submission number K821306, sponsored by Med-Life, 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 1982-06-07.
- Submission: K821306
- Applicant / Sponsor: Med-Life, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1982-06-07
Classification & Regulation
This clearance is catalogued under FDA product code EPW and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.