Clearance Summary
JELENKO NO.1 (CODE NAME RD-0601) received FDA 510(k) clearance under submission number K970068, sponsored by J.F. Jelenko & Co., 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 1997-03-24.
- Submission: K970068
- Applicant / Sponsor: J.F. Jelenko & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 1997-03-24
Classification & Regulation
This clearance is catalogued under FDA product code EJT and 21 CFR 872.3060, within the Dental review panel as a Class II device.