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510(k) Data Aggregation
K Number
K955513Device Name
SURGICAL MASK (NON-STERILE)Manufacturer
Date Cleared
1996-04-22
(140 days)
Product Code
Regulation Number
878.4040Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
UNITED MEDICAL ENT., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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