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510(k) Data Aggregation
K Number
K965015Device Name
TOPAZ 30 SURGICAL LASER SYSTEMManufacturer
Date Cleared
1997-03-14
(88 days)
Product Code
Regulation Number
878.4810Type
TraditionalReference & Predicate Devices
N/A
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Device Name :
TOPAZ 30 SURGICAL LASER SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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