Clearance Summary
GAUZE SPONGE received FDA 510(k) clearance under submission number K953812, sponsored by Remington Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-10-02.
- Submission: K953812
- Applicant / Sponsor: Remington Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6050
- Decision date: 1995-10-02
Classification & Regulation
This clearance is catalogued under FDA product code KHR and 21 CFR 872.6050, within the Dental review panel as a Class I device.