FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER— 510(k) K952343

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

1995-05-19

Decision date

1995-12-22

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 →