Clearance Summary
ACCU-PLACER TM KIT received FDA 510(k) clearance under submission number K912473, 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 1991-07-24.
- Submission: K912473
- Applicant / Sponsor: Hu-Friedy Mfg. Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1991-07-24
Classification & Regulation
This clearance is catalogued under FDA product code EKJ and 21 CFR 872.4565, within the Dental review panel as a Class I device.