HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS— 510(k) K893991

Substantially Equivalent

P & A Co.

FDA 510(k) clearance K893991 for HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS, Substantially Equivalent on 1990-01-11. Applicant: P & A Co..

Clearance details

Applicant: P & A Co.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1989-06-05
Decision date: 1990-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.