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Found 2 results

510(k) Data Aggregation

K Number

Device Name

SURGICAL DRAPES

Manufacturer

ALLEGIANCE HEALTHCARE COPORATION

Date Cleared

2000-08-15

(7 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM

Manufacturer

ALLEGIANCE HEALTHCARE COPORATION

Date Cleared

2000-06-08

(87 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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Ask a specific question about this device

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