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510(k) Data Aggregation
K Number
K000998Device Name
OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSESManufacturer
Date Cleared
2000-06-05
(74 days)
Product Code
Regulation Number
886.5928Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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