Clearance Summary
PERMADYNE GARANT 2:1 received FDA 510(k) clearance under submission number K953374, sponsored by Espe GmbH & Co. Kg.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-08-18.
- Submission: K953374
- Applicant / Sponsor: Espe GmbH & Co. Kg.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 1995-08-18
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.