Clearance Summary
DENTAL UNIT WITH CHAIR received FDA 510(k) clearance under submission number K130410, sponsored by Xianyang North West Medical Instrument (Group) Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2013-07-26.
- Submission: K130410
- Applicant / Sponsor: Xianyang North West Medical Instrument (Group) Co.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2013-07-26
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.