Clearance Summary
'ECURLINE UMBILICAL CORD CLAMP #3500 received FDA 510(k) clearance under submission number K990737, 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 1999-04-06.
- Submission: K990737
- Applicant / Sponsor: Precision Dynamics Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1999-04-06
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.