DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111— 510(k) K990159

Clearance details

Applicant

Dynamic Technology Corp.

Product code

Code FJI

Device class

Class 2

Regulation

21 CFR 876.5820

Advisory panel

Gastroenterology, Urology

Date received

1999-01-19

Decision date

1999-04-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hsinchu, TW

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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 →