Clearance Summary
VITA LAMP, MODEL 0350 received FDA 510(k) clearance under submission number K800067, sponsored by Tensor Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1980-05-08.
- Submission: K800067
- Applicant / Sponsor: Tensor Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6320
- Decision date: 1980-05-08
Classification & Regulation
This clearance is catalogued under FDA product code KZF and 21 CFR 880.6320, within the General Hospital review panel as a Class I device.