Clearance Summary
FLOSPIK received FDA 510(k) clearance under submission number K853767, sponsored by Medelco , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1985-12-02.
- Submission: K853767
- Applicant / Sponsor: Medelco , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6390
- Decision date: 1985-12-02
Classification & Regulation
This clearance is catalogued under FDA product code JES and 21 CFR 872.6390, within the Dental review panel as a Class I device.