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Found 2 results
510(k) Data Aggregation
K Number
K003768Device Name
MONARCH II IOL DELIVERY SYSTEMManufacturer
Date Cleared
2001-01-05
(30 days)
Product Code
Regulation Number
886.4300Type
AbbreviatedPanel
OphthalmicReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MONARCH II IOL DELIVERY SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K001157Device Name
MONARCH II IOL DELIVERY SYSTEMManufacturer
Date Cleared
2000-06-27
(78 days)
Product Code
Regulation Number
886.4300Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MONARCH II IOL DELIVERY SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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