Clearance Summary
QUARTZ RETRACTOR/PROBE received FDA 510(k) clearance under submission number K823792, sponsored by American V. Mueller. 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 1983-01-18.
- Submission: K823792
- Applicant / Sponsor: American V. Mueller
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1983-01-18
Classification & Regulation
This clearance is catalogued under FDA product code KOH and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.