Clearance Summary
RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY received FDA 510(k) clearance under submission number K955679, sponsored by Contour Fabricators of Florida, 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 1996-03-12.
- Submission: K955679
- Applicant / Sponsor: Contour Fabricators of Florida, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.1550
- Decision date: 1996-03-12
Classification & Regulation
This clearance is catalogued under FDA product code HIO and 21 CFR 884.1550, within the Obstetrics/Gynecology review panel as a Class I device.