Clearance Summary
EAR APPLICATOR, CATALOG NO. 2229 received FDA 510(k) clearance under submission number K870762, sponsored by Treace Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1987-03-06.
- Submission: K870762
- Applicant / Sponsor: Treace Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6025
- Decision date: 1987-03-06
Classification & Regulation
This clearance is catalogued under FDA product code KXF and 21 CFR 880.6025, within the General Hospital review panel as a Class I device.