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510(k) Data Aggregation

K Number

Device Name

NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS

Manufacturer

NIKKISO CO. LTD.

Date Cleared

1997-03-19

(573 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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