Clearance Summary
ACTI-FLEX IV ADMINISTRATION SET received FDA 510(k) clearance under submission number K001599, sponsored by R-Group Intl.. 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 2000-09-18.
- Submission: K001599
- Applicant / Sponsor: R-Group Intl.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2000-09-18
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.