K-number	DEN230087
Device name	AMStent® Tracheobronchial Covered Stent System
Applicant	Peytant Solutions, Inc.
Product code	SDB
Device class	Class II
Decision date	Oct 16, 2024
Decision	Not Substantially Equivalent
Regulation	868.3721

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View the full FDA submission: accessdata.fda.gov

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AMStent® Tracheobronchial Covered Stent System

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