Clearance Summary
LAMINARIA JAPONICA CERVICAL DILATOR received FDA 510(k) clearance under submission number K833068, sponsored by Medi-Spec. 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 1984-02-04.
- Submission: K833068
- Applicant / Sponsor: Medi-Spec
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4260
- Decision date: 1984-02-04
Classification & Regulation
This clearance is catalogued under FDA product code HDY and 21 CFR 884.4260, within the Obstetrics/Gynecology review panel as a Class II device.