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510(k) Data Aggregation

K Number

Device Name

RADIOLUCENT COLLES FRACTURE KIT

Manufacturer

Date Cleared

2000-08-31

(83 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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AI/ML Overview

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