Clearance Summary
FLORIDA PROBE received FDA 510(k) clearance under submission number K875076, sponsored by Florida Probe Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1988-03-10.
- Submission: K875076
- Applicant / Sponsor: Florida Probe Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1988-03-10
Classification & Regulation
This clearance is catalogued under FDA product code EIX and 21 CFR 872.4565, within the Dental review panel as a Class I device.