Clearance Summary
MEDI-TECH DILATATION CATHETERS received FDA 510(k) clearance under submission number K844292, sponsored by Medi-Tech, 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 1984-11-23.
- Submission: K844292
- Applicant / Sponsor: Medi-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1984-11-23
Classification & Regulation
This clearance is catalogued under FDA product code LCN and 21 CFR 872.6855, within the Dental review panel as a Class I device.