Clearance Summary
COVERAGE HBV received FDA 510(k) clearance under submission number K964749, sponsored by Convatec, A Division of E.R. Squibb & Sons. 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 1996-12-13.
- Submission: K964749
- Applicant / Sponsor: Convatec, A Division of E.R. Squibb & Sons
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6890
- Decision date: 1996-12-13
Classification & Regulation
This clearance is catalogued under FDA product code LRJ and 21 CFR 880.6890, within the General Hospital review panel as a Class I device.