Clearance Summary
SIROLUX FANTASTIC received FDA 510(k) clearance under submission number K935390, sponsored by Pelton & Crane Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-12-10.
- Submission: K935390
- Applicant / Sponsor: Pelton & Crane Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4630
- Decision date: 1993-12-10
Classification & Regulation
This clearance is catalogued under FDA product code EAZ and 21 CFR 872.4630, within the Dental review panel as a Class I device.