Clearance Summary
CELSITE, MODELS ST401L, ST405L received FDA 510(k) clearance under submission number K994111, sponsored by B. Braun/Mcgaw. 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 2000-01-03.
- Submission: K994111
- Applicant / Sponsor: B. Braun/Mcgaw
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 2000-01-03
Classification & Regulation
This clearance is catalogued under FDA product code LJT and 21 CFR 880.5965, within the General Hospital review panel as a Class II device.