Clearance Summary
OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02 received FDA 510(k) clearance under submission number K901963, sponsored by Omron Marshall Products, 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 1990-06-26.
- Submission: K901963
- Applicant / Sponsor: Omron Marshall Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 1990-06-26
Classification & Regulation
This clearance is catalogued under FDA product code JEQ and 21 CFR 872.6865, within the Dental review panel as a Class I device.