FDA 510(k) Application Details - K162578

Device Classification Name	More FDA Info for this Device
510(K) Number	K162578
Device Name	Zerona Z6 OTC
Applicant	ERCHONIA CORPORATION 650 ATLANTIS RD MELBOURNE, FL 32904 US Other 510(k) Applications for this Company
Contact	STEVEN SHANKS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2016
Decision Date	12/16/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review