Clearance Summary
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 received FDA 510(k) clearance under submission number K052055, sponsored by Smisson-Cartledge Biomedical, LLC. 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 2006-10-26.
- Submission: K052055
- Applicant / Sponsor: Smisson-Cartledge Biomedical, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2006-10-26
Classification & Regulation
This clearance is catalogued under FDA product code LGZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.