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510(k) Data Aggregation
K Number
K003820Device Name
DISPOSABLE CB-PE MICROKERATOME BLADESManufacturer
Date Cleared
2001-03-08
(87 days)
Product Code
Regulation Number
886.4370Type
TraditionalPanel
Ophthalmic (OP)Reference & Predicate Devices
N/A
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Device Name :
DISPOSABLE CB-PE MICROKERATOME BLADES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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