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510(k) Data Aggregation
K Number
K000442Manufacturer
Date Cleared
2001-04-24
(439 days)
Product Code
Regulation Number
878.4370Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
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Device Name :
ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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