Clearance Summary
ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN received FDA 510(k) clearance under submission number K920819, sponsored by Astra Meditec AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1993-03-24.
- Submission: K920819
- Applicant / Sponsor: Astra Meditec AB
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4680
- Decision date: 1993-03-24
Classification & Regulation
This clearance is catalogued under FDA product code GCY and 21 CFR 878.4680, within the General, Plastic Surgery review panel as a Class I device.