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510(k) Data Aggregation

K Number

Device Name

MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.

Manufacturer

MEDLINE INDUSTRIES, INC.

Date Cleared

2006-02-16

(191 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

To be used as a urological catheter inserted through the urethra to pass urine from urinary tract.

Device Description

Medline Silver Touch™ Silicone Foley Catheter

AI/ML Overview

I'm sorry, but this document is unrelated to AI/ML device review. It is a 510(k) premarket notification for a traditional medical device (Foley catheter) and does not contain any information about acceptance criteria or study data for an AI/ML device. Therefore, I cannot provide the requested information based on the provided text.

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