Clearance Summary
ATTIC DEFECT PLATE received FDA 510(k) clearance under submission number K921433, sponsored by Smith & Nephew Richards, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1993-03-18.
- Submission: K921433
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3430
- Decision date: 1993-03-18
Classification & Regulation
This clearance is catalogued under FDA product code ETC and 21 CFR 874.3430, within the Ear, Nose, Throat review panel as a Class II device.