Clearance Summary
THERMOMETER JARS AND CAPS received FDA 510(k) clearance under submission number K760909, sponsored by Plastics/Packaging. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1976-12-30.
- Submission: K760909
- Applicant / Sponsor: Plastics/Packaging
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3910
- Decision date: 1976-12-30
Classification & Regulation
This clearance is catalogued under FDA product code ELK and 21 CFR 872.3910, within the Dental review panel as a Class I device.