FDA 510(k) Application Details - K980657

Device Classification Name	Implant, Eye Valve   More FDA Info for this Device
510(K) Number	K980657
Device Name	Implant, Eye Valve
Applicant	NEW WORLD MEDICAL, INC. 10574 ACACIA ST. SUITE D-1 RANCHO CUCAMONGA, CA 91730 US Other 510(k) Applications for this Company
Contact	A.M. AHMED 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	02/05/1998
Decision Date	04/20/1998
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