Clearance Summary
HAPEX MALLEABLE TORP received FDA 510(k) clearance under submission number K950927, 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 1995-03-21.
- Submission: K950927
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3495
- Decision date: 1995-03-21
Classification & Regulation
This clearance is catalogued under FDA product code ETA and 21 CFR 874.3495, within the Ear, Nose, Throat review panel as a Class II device.