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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tracheal, Expandable
510(k) Number K083625
Device Name AERO DV TRACHEOBRONCHIAL STENT SYSTEM
Applicant
Alveolus, Inc.
9013 Perimeter Woods Dr.
Suite A
Charlotte,  NC  28216
Applicant Contact TONY ALEXANDER
Correspondent
Alveolus, Inc.
9013 Perimeter Woods Dr.
Suite A
Charlotte,  NC  28216
Correspondent Contact TONY ALEXANDER
Regulation Number878.3720
Classification Product Code
JCT  
Date Received12/08/2008
Decision Date 03/11/2009
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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