Clearance Summary
SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 received FDA 510(k) clearance under submission number K994263, sponsored by Precision Dynamics 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 2000-01-24.
- Submission: K994263
- Applicant / Sponsor: Precision Dynamics Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2000-01-24
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.