FDA 510(k) Application Details - K131692

Device Classification Name	Expander, Skin, Inflatable   More FDA Info for this Device
510(K) Number	K131692
Device Name	Expander, Skin, Inflatable
Applicant	MARZ MEDICAL, INC 2500 HOSPITAL DRIVE BUILDING 9 MOUNTAIN VIEW, CA 94040 US Other 510(k) Applications for this Company
Contact	MARY PASCUAL GALLUP Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2013
Decision Date	07/10/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review