Clearance Summary
WAGGONER DENTAL MANUFACTURING STERIWATER SYSTEM received FDA 510(k) clearance under submission number K925829, sponsored by Waggoner Dental Mfg.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-02-12.
- Submission: K925829
- Applicant / Sponsor: Waggoner Dental Mfg.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1993-02-12
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.