Clearance Summary
OSSTAPLE, MAXILLOFACIAL received FDA 510(k) clearance under submission number K023486, sponsored by Biomedical Enterprises, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-10-31.
- Submission: K023486
- Applicant / Sponsor: Biomedical Enterprises, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2002-10-31
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.