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510(k) Data Aggregation
K Number
DEN040009Manufacturer
Date Cleared
2004-11-04
(71 days)
Product Code
Regulation Number
884.6200Type
Post-NSEReference & Predicate Devices
N/A
Why did this record match?
Device Name :
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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