FDA 510(k) Application Details - K161483

Device Classification Name	Expander, Skin, Inflatable   More FDA Info for this Device
510(K) Number	K161483
Device Name	Expander, Skin, Inflatable
Applicant	STRADIS HEALTHCARE 805 MARATHON PKWY SUITE 100 LAWRENCEVILLE, GA 30046 US Other 510(k) Applications for this Company
Contact	Joseph Trznadel 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	05/31/2016
Decision Date	10/31/2016
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