HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R— 510(k) K914790

Clearance details

Applicant

National Medical Care, Medical Products Div., Inc.

Product code

Code FJI

Device class

Class 2

Regulation

21 CFR 876.5820

Advisory panel

Gastroenterology, Urology

Date received

1991-10-23

Decision date

1993-03-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rockleigh, NJ, US

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Death

2

Total

2

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 →