Clearance Summary
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 received FDA 510(k) clearance under submission number K083780, sponsored by Audio Technologies S.R.L.. 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 2009-03-23.
- Submission: K083780
- Applicant / Sponsor: Audio Technologies S.R.L.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3495
- Decision date: 2009-03-23
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.