Clearance Summary
AMNIPERF(TM) received FDA 510(k) clearance under submission number K926425, sponsored by Raymart Development Co.. 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 1994-03-07.
- Submission: K926425
- Applicant / Sponsor: Raymart Development Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1994-03-07
Classification & Regulation
This clearance is catalogued under FDA product code HGE and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.