Clearance Summary
BABY TEETHER, MODEL 20104 received FDA 510(k) clearance under submission number K014023, sponsored by Angelina Trading, 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 2002-08-02.
- Submission: K014023
- Applicant / Sponsor: Angelina Trading, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5550
- Decision date: 2002-08-02
Classification & Regulation
This clearance is catalogued under FDA product code KKO and 21 CFR 872.5550, within the Dental review panel as a Class II device.