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510(k) Data Aggregation
K Number
K002647Manufacturer
Date Cleared
2000-09-13
(20 days)
Product Code
Regulation Number
886.5925Type
TraditionalPanel
Ophthalmic (OP)Reference & Predicate Devices
N/A
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Device Name :
MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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