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510(k) Data Aggregation
K Number
K010068Manufacturer
Date Cleared
2001-02-08
(31 days)
Product Code
Regulation Number
878.3610Type
AbbreviatedReference & Predicate Devices
N/A
Why did this record match?
Device Name :
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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