Clearance Summary
UMBILICAL CORD CLAMP AND CUTTER received FDA 510(k) clearance under submission number K901557, sponsored by Microtek-Heritage, Inc.. 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 1990-05-15.
- Submission: K901557
- Applicant / Sponsor: Microtek-Heritage, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1990-05-15
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.