FDA 510(k) Application Details - K170075

Device Classification Name	More FDA Info for this Device
510(K) Number	K170075
Device Name	AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
Applicant	AirXpanders, Inc. 1047 Elwell Ct. Palo Alto, CA 94303 US Other 510(k) Applications for this Company
Contact	Belinda Pinedo 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	01/09/2017
Decision Date	04/03/2017
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