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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE

Manufacturer

Date Cleared

2000-10-19

(238 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD

Manufacturer

Date Cleared

2000-10-19

(127 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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