Clearance Summary
HERO 642 received FDA 510(k) clearance under submission number K970649, sponsored by Micro-Mega. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-05-16.
- Submission: K970649
- Applicant / Sponsor: Micro-Mega
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1997-05-16
Classification & Regulation
This clearance is catalogued under FDA product code EKS and 21 CFR 872.4565, within the Dental review panel as a Class I device.