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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

WALLSTENT ENTERNAL PROSTHESIS

Manufacturer

BOSTON SCIENTIFIC CORP.

Date Cleared

2000-05-12

(102 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K042065,K060323,K061877,K062750,K113510

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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