Clearance Summary
DRAIN-R-DRAPE(EYE received FDA 510(k) clearance under submission number K831340, sponsored by Sur-Tech, 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 1983-06-08.
- Submission: K831340
- Applicant / Sponsor: Sur-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1983-06-08
Classification & Regulation
This clearance is catalogued under FDA product code HMT and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.