Clearance Summary
NEO-CARE DUAL LUMEN UMBILICAL CATHETER received FDA 510(k) clearance under submission number K963972, sponsored by Klein-Baker Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1996-12-24.
- Submission: K963972
- Applicant / Sponsor: Klein-Baker Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1996-12-24
Classification & Regulation
This clearance is catalogued under FDA product code FOS and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.