Clearance Summary
COTTON FILLED GAUZE SPONGES 2 X 2 received FDA 510(k) clearance under submission number K861727, sponsored by Cross Country Paper Products Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-07-10.
- Submission: K861727
- Applicant / Sponsor: Cross Country Paper Products Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6050
- Decision date: 1986-07-10
Classification & Regulation
This clearance is catalogued under FDA product code EFN and 21 CFR 872.6050, within the Dental review panel as a Class I device.