Clearance Summary
FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) received FDA 510(k) clearance under submission number K812981, sponsored by Venusa , Ltd.. 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 1981-11-06.
- Submission: K812981
- Applicant / Sponsor: Venusa , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1981-11-06
Classification & Regulation
This clearance is catalogued under FDA product code FPK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.