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510(k) Data Aggregation
K Number
K950688Manufacturer
Date Cleared
1996-04-18
(429 days)
Product Code
Regulation Number
870.2300Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
SAFETY TEK CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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