Clearance Summary
SLIP-ON FIXATION SPLINT (SFS) received FDA 510(k) clearance under submission number K934468, sponsored by Gatewood Splints. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-08-05.
- Submission: K934468
- Applicant / Sponsor: Gatewood Splints
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3165
- Decision date: 1994-08-05
Classification & Regulation
This clearance is catalogued under FDA product code EHO and 21 CFR 872.3165, within the Dental review panel as a Class I device.