Clearance Summary
BOIES NASAL FRACTURE ELEVATOR received FDA 510(k) clearance under submission number K772391, sponsored by Edward Weck, 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 1978-01-17.
- Submission: K772391
- Applicant / Sponsor: Edward Weck, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1978-01-17
Classification & Regulation
This clearance is catalogued under FDA product code KAD and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.