Clearance Summary
CERETENE SOLUBLE IMPLANT MATERIAL received FDA 510(k) clearance under submission number K103047, sponsored by Ceremed , 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 2011-01-05.
- Submission: K103047
- Applicant / Sponsor: Ceremed , Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 2011-01-05
Classification & Regulation
This clearance is catalogued under FDA product code KHJ and 21 CFR 874.3620, within the Ear, Nose, Throat review panel as a Class II device.