FDA 510(k) Application Details - K162060

Device Classification Name	Implant, Eye Valve   More FDA Info for this Device
510(K) Number	K162060
Device Name	Implant, Eye Valve
Applicant	NEW WORLD MEDICAL, INC. 10763 EDISON COURT RANCHO CUCAMONGA, CA 91730 US Other 510(k) Applications for this Company
Contact	SUHAIL ABDULLAH Other 510(k) Applications for this Contact
Regulation Number	886.3920   More FDA Info for this Regulation Number
Classification Product Code	KYF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2016
Decision Date	10/24/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review