Clearance Summary
VACCON received FDA 510(k) clearance under submission number K896733, sponsored by Unoplast A/S. 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 1990-02-01.
- Submission: K896733
- Applicant / Sponsor: Unoplast A/S
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 1990-02-01
Classification & Regulation
This clearance is catalogued under FDA product code KGX and 21 CFR 880.5240, within the General Hospital review panel as a Class I device.