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Found 2 results
510(k) Data Aggregation
K Number
K963417Device Name
VITLITE (TR7700)Manufacturer
Date Cleared
1996-12-20
(112 days)
Product Code
Regulation Number
876.1500Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
ESCALON TREK MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K963434Device Name
VISCOUS FLUID SYSTEMManufacturer
Date Cleared
1996-11-25
(87 days)
Product Code
Regulation Number
880.5725Type
TraditionalPanel
OphthalmicReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
ESCALON TREK MEDICAL
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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