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510(k) Data Aggregation

K Number

Device Name

TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION

Manufacturer

KLS-MARTIN L.P.

Date Cleared

2000-10-10

(85 days)

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Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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