Clearance Summary
WELLINGTON HOSPITAL PATTERN SELF-RETAIN received FDA 510(k) clearance under submission number K843388, sponsored by Downs Surgical , 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 1984-10-01.
- Submission: K843388
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1984-10-01
Classification & Regulation
This clearance is catalogued under FDA product code HDF and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.