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Found 3 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS

Manufacturer

GO MEDICAL INDUSTRIES PTY. LTD.

Date Cleared

2001-06-06

(61 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

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 O'NEIL STERILE FIELD URINARY CATHETER KIT

Manufacturer

GO MEDICAL INDUSTRIES PTY. LTD.

Date Cleared

2000-12-27

(110 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

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

Ask a Question

Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

GO MEDICAL BALLOON INFUSION SYSTEM

Manufacturer

GO MEDICAL INDUSTRIES PTY. LTD.

Date Cleared

2000-05-09

(102 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

Ask a Question

Ask a specific question about this device

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