Clearance Summary
FOCUS FLUID received FDA 510(k) clearance under submission number K830187, sponsored by Hematology Marketing Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1983-03-01.
- Submission: K830187
- Applicant / Sponsor: Hematology Marketing Assoc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1983-03-01
Classification & Regulation
This clearance is catalogued under FDA product code EIF and 21 CFR 872.4565, within the Dental review panel as a Class I device.