Clearance Summary
VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS received FDA 510(k) clearance under submission number K991005, sponsored by Dayspring Medical, 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 1999-06-22.
- Submission: K991005
- Applicant / Sponsor: Dayspring Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1999-06-22
Classification & Regulation
This clearance is catalogued under FDA product code LLB and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.