Clearance Summary
DRAGER GEMINA WALL-MOUNTED WORKPLACE received FDA 510(k) clearance under submission number K961886, sponsored by Alm Surgical Equipment, 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 1996-07-30.
- Submission: K961886
- Applicant / Sponsor: Alm Surgical Equipment, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1996-07-30
Classification & Regulation
This clearance is catalogued under FDA product code FQO and 21 CFR 878.4960, within the General, Plastic Surgery review panel as a Class I device.