Clearance Summary
CONTAIN X-RAY DETECTABLE LAP SPONGE received FDA 510(k) clearance under submission number K801768, sponsored by The Buckeye Cellulose Corp.. 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 1980-08-20.
- Submission: K801768
- Applicant / Sponsor: The Buckeye Cellulose Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4450
- Decision date: 1980-08-20
Classification & Regulation
This clearance is catalogued under FDA product code GDY and 21 CFR 878.4450, within the General, Plastic Surgery review panel as a Class I device.