Clearance Summary
PDS-2000 received FDA 510(k) clearance under submission number K902653, sponsored by Intl. Equipment and Supply Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-09-13.
- Submission: K902653
- Applicant / Sponsor: Intl. Equipment and Supply Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1990-09-13
Classification & Regulation
This clearance is catalogued under FDA product code EIK and 21 CFR 872.4565, within the Dental review panel as a Class I device.