Clearance Summary
CIN-SHEAR received FDA 510(k) clearance under submission number K840352, 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 1984-04-05.
- Submission: K840352
- Applicant / Sponsor: Roland J. Zwick, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1984-04-05
Classification & Regulation
This clearance is catalogued under FDA product code HFB and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.