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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name tracheal prosthesis with cover material derived from human sources
De Novo Number DEN230087
Device Name AMStent® Tracheobronchial Covered Stent System
Requester
peytant solutions, inc.
3650 annapolis lane north, #180
plymouth,  MN  55447
Contact john schorgl
Regulation Number868.3721
Classification Product Code
SDB  
Date Received12/20/2023
Decision Date 10/16/2024
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Classification Order Classification Order
Type Direct
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