Clearance Summary
BURN DRESSING PAD received FDA 510(k) clearance under submission number K780418, sponsored by The Owenby Co.. 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 1978-04-10.
- Submission: K780418
- Applicant / Sponsor: The Owenby Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5180
- Decision date: 1978-04-10
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.