Clearance Summary
IMPLANTECH MEDICAL GRADE SILICONE SHEETING received FDA 510(k) clearance under submission number K944408, sponsored by King & Spalding. 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 1994-11-09.
- Submission: K944408
- Applicant / Sponsor: King & Spalding
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 1994-11-09
Classification & Regulation
This clearance is catalogued under FDA product code MIB and 21 CFR 874.3620, within the Ear, Nose, Throat review panel as a Class II device.