Clearance Summary
R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE received FDA 510(k) clearance under submission number K940319, 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 1994-11-10.
- Submission: K940319
- Applicant / Sponsor: R-Group Intl.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1994-11-10
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.