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510(k) Data Aggregation
K Number
K963348Device Name
WALLACH INTEGRATION UNITManufacturer
Date Cleared
1997-03-19
(205 days)
Product Code
Regulation Number
884.4120Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
WALLACH INTEGRATION UNIT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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