Clearance Summary
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS received FDA 510(k) clearance under submission number K013587, sponsored by Babies Best, 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 2002-05-14.
- Submission: K013587
- Applicant / Sponsor: Babies Best, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5550
- Decision date: 2002-05-14
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.