Clearance Summary
INTRAUTERINE DEVICE REMOVER received FDA 510(k) clearance under submission number K842295, sponsored by Premier Dental Products Co.. 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 1984-10-12.
- Submission: K842295
- Applicant / Sponsor: Premier Dental Products Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1984-10-12
Classification & Regulation
This clearance is catalogued under FDA product code HHF and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.