Clearance Summary
OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE received FDA 510(k) clearance under submission number K896821, sponsored by North American Sterilization & Packaging Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-02-09.
- Submission: K896821
- Applicant / Sponsor: North American Sterilization & Packaging Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3410
- Decision date: 1990-02-09
Classification & Regulation
This clearance is catalogued under FDA product code KOQ and 21 CFR 872.3410, within the Dental review panel as a Class I device.