Clearance Summary
CANNULATED INSTRUMENT CLEANERS received FDA 510(k) clearance under submission number K870765, sponsored by Treace 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 1987-05-27.
- Submission: K870765
- Applicant / Sponsor: Treace Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1987-05-27
Classification & Regulation
This clearance is catalogued under FDA product code EKW and 21 CFR 872.4565, within the Dental review panel as a Class I device.