Clearance Summary
FRESENIUS PD+ EXCHANGE DEVICE received FDA 510(k) clearance under submission number K915634, sponsored by Fresenius USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-07-01.
- Submission: K915634
- Applicant / Sponsor: Fresenius USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1993-07-01
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.