Clearance Summary
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR received FDA 510(k) clearance under submission number K980917, sponsored by Fortune Medical Instrument Corp.. 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 1998-05-27.
- Submission: K980917
- Applicant / Sponsor: Fortune Medical Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 1998-05-27
Classification & Regulation
This clearance is catalogued under FDA product code GCA and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.