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FDA 510(k) Application Details - K031641
Device Classification Name
Prosthesis, Tracheal, Expandable
More FDA Info for this Device
510(K) Number
K031641
Device Name
Prosthesis, Tracheal, Expandable
Applicant
VASCULAR ARCHITECTS, INC.
1830 BERING DR.
SAN JOSE, CA 95112-4226 US
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Contact
PHYLLIS ELSON
Other 510(k) Applications for this Contact
Regulation Number
878.3720
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Classification Product Code
JCT
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More FDA Info for this Product Code
Date Received
05/27/2003
Decision Date
08/01/2003
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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