Clearance Summary
LOW PROFILE LUTHER SAFETY HUBER received FDA 510(k) clearance under submission number K040527, sponsored by Luther Needlesafe Products, Inc.. 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 2004-03-26.
- Submission: K040527
- Applicant / Sponsor: Luther Needlesafe Products, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2004-03-26
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.