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510(k) Data Aggregation
K Number
K001923Manufacturer
Date Cleared
2000-08-25
(63 days)
Product Code
Regulation Number
890.3860Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
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Applicant Name (Manufacturer) :
GENDRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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