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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 K071604
Device Name ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM
Applicant
ALVEOLUS, INC
9013 PERIMETER WOODS DR.
SUITE A
CHARLOTTE,  NC  28216
Applicant Contact DONALD V CANAL
Correspondent
ALVEOLUS, INC
9013 PERIMETER WOODS DR.
SUITE A
CHARLOTTE,  NC  28216
Correspondent Contact DONALD V CANAL
Regulation Number878.3720
Classification Product Code
JCT  
Date Received06/12/2007
Decision Date 09/19/2007
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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