Clearance Summary
SPLIT SEPTUM INJECTION SITES received FDA 510(k) clearance under submission number K041042, sponsored by Fresenius Medical Care North America. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2004-07-16.
- Submission: K041042
- Applicant / Sponsor: Fresenius Medical Care North America
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2004-07-16
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.