FDA 510(k) Application Details - K182518

Device Classification Name	Implant, Eye Valve   More FDA Info for this Device
510(K) Number	K182518
Device Name	Implant, Eye Valve
Applicant	New World Medical, Inc. 10763 Edison Ct Rancho Cucamonga, CA 91730 US Other 510(k) Applications for this Company
Contact	Mukesh Sabarad 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	09/13/2018
Decision Date	01/18/2019
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