Clearance Summary
EI DOWNPAK BARRIER SLEEVES received FDA 510(k) clearance under submission number K073369, sponsored by Hu-Friedy Mfg. 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 2008-02-27.
- Submission: K073369
- Applicant / Sponsor: Hu-Friedy Mfg. Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3850
- Decision date: 2008-02-27
Classification & Regulation
This clearance is catalogued under FDA product code EKM and 21 CFR 872.3850, within the Dental review panel as a Class I device.