Clearance Summary
CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON received FDA 510(k) clearance under submission number K930034, sponsored by Thomasville Medical Assoc.. 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 1994-02-24.
- Submission: K930034
- Applicant / Sponsor: Thomasville Medical Assoc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1994-02-24
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.