Clearance Summary
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B received FDA 510(k) clearance under submission number K012917, sponsored by Dynarex Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2001-11-28.
- Submission: K012917
- Applicant / Sponsor: Dynarex Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2001-11-28
Classification & Regulation
This clearance is catalogued under FDA product code HFW and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.