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FDA 510(k) Application Details - K071604
Device Classification Name
Prosthesis, Tracheal, Expandable
More FDA Info for this Device
510(K) Number
K071604
Device Name
Prosthesis, Tracheal, Expandable
Applicant
ALVEOLUS, INC
9013 PERIMETER WOODS DR.
SUITE A
CHARLOTTE, NC 28216 US
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Contact
DONALD V CANAL
Other 510(k) Applications for this Contact
Regulation Number
878.3720
More FDA Info for this Regulation Number
Classification Product Code
JCT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/12/2007
Decision Date
09/19/2007
Decision
SESU - SE - WITH LIMITATIONS
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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