Clearance Summary
PERITONEAL DIALYSIS SYSTEM received FDA 510(k) clearance under submission number K760724, sponsored by Physio-Control 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 1976-11-23.
- Submission: K760724
- Applicant / Sponsor: Physio-Control Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1976-11-23
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.