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510(k) Data Aggregation

K Number

Device Name

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

Manufacturer

FRESENIUS MEDICAL CARE NORTH AMERICA

Date Cleared

2000-12-04

(90 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology-Urology (GU)

Reference & Predicate Devices

N/A

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Device Name :

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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