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510(k) Data Aggregation
K Number
K980522Device Name
REFRACTEC MCS-100Manufacturer
Date Cleared
1998-07-22
(162 days)
Product Code
Regulation Number
886.4100Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
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Device Name :
REFRACTEC MCS-100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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