Clearance Summary
CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS received FDA 510(k) clearance under submission number K934610, sponsored by Tabex Industries, Inc.. 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 1994-09-23.
- Submission: K934610
- Applicant / Sponsor: Tabex Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1994-09-23
Classification & Regulation
This clearance is catalogued under FDA product code FJS and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.