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Found 5 results
510(k) Data Aggregation
K Number
K003036Device Name
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Manufacturer
Date Cleared
2000-12-22
(84 days)
Product Code
Regulation Number
886.4360Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
RETINALABS.COM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K000418Device Name
PDT DOSECALCULATOR, MODEL 80000Manufacturer
Date Cleared
2000-10-24
(259 days)
Product Code
Regulation Number
868.1890Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
RETINALABS.COM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K000457Manufacturer
Date Cleared
2000-05-09
(88 days)
Product Code
Regulation Number
886.4350Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
RETINALABS.COM
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
K Number
K000416Manufacturer
Date Cleared
2000-05-08
(90 days)
Product Code
Regulation Number
876.1500Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
RETINALABS.COM
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
K Number
K000420Manufacturer
Date Cleared
2000-05-08
(90 days)
Product Code
Regulation Number
880.5725Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
RETINALABS.COM
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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