Clearance Summary
BURNSHIELD TRAUMA DRESSING received FDA 510(k) clearance under submission number K921471, sponsored by Levtrade Intl. (Pty) , 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 1993-04-20.
- Submission: K921471
- Applicant / Sponsor: Levtrade Intl. (Pty) , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5180
- Decision date: 1993-04-20
Classification & Regulation
This clearance is catalogued under FDA product code FPY and 21 CFR 880.5180, within the General Hospital review panel as a Class I device.