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FDA 510(k) Application Details - DEN150055
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN150055
Device Name
AeroForm Tissue Expander System
Applicant
AIRXPANDERS, INC
1047 ELWELL COURT
PALO ALTO, CA 94303 US
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Contact
Robin` Bush
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PQN
Other 510(k) Applications for this Device
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Date Received
12/07/2015
Decision Date
12/21/2016
Decision
DENG -
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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