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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 K033990
Device Name ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
Applicant
ALVEOLUS, INC.
9013 PERIMETER WOODS SUITE A
CHARLOTTE,  NC  28216
Applicant Contact HOWARD L SCHRAYER
Correspondent
ALVEOLUS, INC.
9013 PERIMETER WOODS SUITE A
CHARLOTTE,  NC  28216
Correspondent Contact HOWARD L SCHRAYER
Regulation Number878.3720
Classification Product Code
JCT  
Date Received12/23/2003
Decision Date 05/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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