Clearance Summary
PEDIATRIC DRAIN BAG received FDA 510(k) clearance under submission number K896581, sponsored by Laytech Medical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1990-01-31.
- Submission: K896581
- Applicant / Sponsor: Laytech Medical Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1990-01-31
Classification & Regulation
This clearance is catalogued under FDA product code FFH and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class II device.