Clearance Summary
DIRECT ANTIBIOTIC INFUSION KIT received FDA 510(k) clearance under submission number K113043, sponsored by Summit Medical Products, 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 2011-12-20.
- Submission: K113043
- Applicant / Sponsor: Summit Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2011-12-20
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.