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 Other 510(k) Applications for this Company
Contact	Robin` Bush Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQN Other 510(k) Applications for this Device   More FDA Info for this Product Code
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