Clearance Summary
BONE GRAFT DELIVERY SYRINGES received FDA 510(k) clearance under submission number K941431, sponsored by Bio-Interfaces, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-07-12.
- Submission: K941431
- Applicant / Sponsor: Bio-Interfaces, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1994-07-12
Classification & Regulation
This clearance is catalogued under FDA product code EID and 21 CFR 872.4565, within the Dental review panel as a Class I device.