Clearance Summary
MODEL 0450000, OPAL MEDICAL EXAM LIGHT received FDA 510(k) clearance under submission number K893808, sponsored by Burton Medical Products Corp.. 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 1989-08-15.
- Submission: K893808
- Applicant / Sponsor: Burton Medical Products Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6320
- Decision date: 1989-08-15
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.