Clearance Summary
LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM received FDA 510(k) clearance under submission number K021012, sponsored by Quality Medical Solusions, LLC. 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 2002-06-25.
- Submission: K021012
- Applicant / Sponsor: Quality Medical Solusions, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4260
- Decision date: 2002-06-25
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.