Clearance Summary
VITAFLON PLUS/VASCULON received FDA 510(k) clearance under submission number K941417, sponsored by Hogan & Hartson. 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 1994-10-06.
- Submission: K941417
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1994-10-06
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.