Clearance Summary
A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) received FDA 510(k) clearance under submission number K897195, sponsored by A Company, 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 1990-05-31.
- Submission: K897195
- Applicant / Sponsor: A Company, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1990-05-31
Classification & Regulation
This clearance is catalogued under FDA product code EKS and 21 CFR 872.4565, within the Dental review panel as a Class I device.