Clearance Summary
MMODIFICATION TO LAMINARIA received FDA 510(k) clearance under submission number K011512, sponsored by A & A Medical, 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 2001-07-09.
- Submission: K011512
- Applicant / Sponsor: A & A Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4260
- Decision date: 2001-07-09
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.