Clearance Summary
SAFETY RELEASE MODULE received FDA 510(k) clearance under submission number K961754, sponsored by G & H Wire Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1996-07-10.
- Submission: K961754
- Applicant / Sponsor: G & H Wire Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5500
- Decision date: 1996-07-10
Classification & Regulation
This clearance is catalogued under FDA product code DZB and 21 CFR 872.5500, within the Dental review panel as a Class II device.