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FDA 510(k) Application Details - K033053
Device Classification Name
Prosthesis, Tracheal, Expandable
More FDA Info for this Device
510(K) Number
K033053
Device Name
Prosthesis, Tracheal, Expandable
Applicant
ALVEOLUS, INC.
9013 PERIMETER WOODS SUITE A
CHARLOTTE, NC 28216 US
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Contact
Howard Schrayer
Other 510(k) Applications for this Contact
Regulation Number
878.3720
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Classification Product Code
JCT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2003
Decision Date
02/25/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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