FDA 510(k) Application Details - K012852

Device Classification Name	Implant, Eye Valve   More FDA Info for this Device
510(K) Number	K012852
Device Name	Implant, Eye Valve
Applicant	OPTONOL, LTD 12300 TWINBROOK PKWY, STE 625 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	RICHARD E LIPPMAN 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	08/24/2001
Decision Date	03/26/2002
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