Clearance Summary
TYCO BABY SESAME STREET SOFT TEETHER received FDA 510(k) clearance under submission number K963912, sponsored by Regu-Tech Assoc., 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 1996-11-06.
- Submission: K963912
- Applicant / Sponsor: Regu-Tech Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5550
- Decision date: 1996-11-06
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.