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510(k) Data Aggregation
K Number
K963128Device Name
NOVAGEL SILICONE GEL SHEETINGManufacturer
Date Cleared
1996-12-05
(115 days)
Product Code
Regulation Number
878.4025Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
NOVAGEL SILICONE GEL SHEETING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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