Clearance Summary
DISPO-URETTE received FDA 510(k) clearance under submission number K860796, sponsored by Roland J. Zwick, 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 1986-04-08.
- Submission: K860796
- Applicant / Sponsor: Roland J. Zwick, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1050
- Decision date: 1986-04-08
Classification & Regulation
This clearance is catalogued under FDA product code PCF and 21 CFR 884.1050, within the Obstetrics/Gynecology review panel as a Class II device.