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K Number
K002515
Device Name
MEDLOGICS ML 4000, MODEL 4000
Manufacturer
MED-LOGICS, INC.
Date Cleared
2001-02-22

(191 days)

Product Code
HNO
Regulation Number
886.4370
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 886.4370 Keratome.

(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.