Clearance Summary
HARWILL MEDICAL U-KLIP UMBILICAL CLAMP received FDA 510(k) clearance under submission number K983204, sponsored by Harwill Medical (Pty) , Ltd.. 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 1999-02-26.
- Submission: K983204
- Applicant / Sponsor: Harwill Medical (Pty) , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1999-02-26
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.