Clearance Summary
CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL received FDA 510(k) clearance under submission number K891029, sponsored by Zinnanti Surgical Instruments, 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 1989-03-17.
- Submission: K891029
- Applicant / Sponsor: Zinnanti Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1989-03-17
Classification & Regulation
This clearance is catalogued under FDA product code HDQ and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.