FDA 510(k) Application Details - K191138

Device Classification Name	More FDA Info for this Device
510(K) Number	K191138
Device Name	AeroForm Tissue Expander, Smooth
Applicant	AirXpanders, Inc. 3047 Orchard Parkway San Jose, CA 95134 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	04/30/2019
Decision Date	07/11/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review