Clearance Summary
PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI received FDA 510(k) clearance under submission number K991003, 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 1999-06-09.
- Submission: K991003
- Applicant / Sponsor: Dayspring Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1999-06-09
Classification & Regulation
This clearance is catalogued under FDA product code FKY and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.