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510(k) Data Aggregation
K Number
K001144Device Name
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACSManufacturer
Date Cleared
2000-05-05
(25 days)
Product Code
Regulation Number
886.4370Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
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Device Name :
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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