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510(k) Data Aggregation

K Number

Device Name

REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)

Manufacturer

GAMBRO HEALTHCARE

Date Cleared

1996-08-28

(328 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

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Device Name :

REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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