Clearance Summary
TISSUE INTEGRATED PROSTHESIS DRILL received FDA 510(k) clearance under submission number K841813, sponsored by Bofors Nobelpharma, 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 1984-08-10.
- Submission: K841813
- Applicant / Sponsor: Bofors Nobelpharma, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4250
- Decision date: 1984-08-10
Classification & Regulation
This clearance is catalogued under FDA product code ERL and 21 CFR 874.4250, within the Ear, Nose, Throat review panel as a Class II device.