FDA 510(k) Application Details - K012096

Device Classification Name	Lens, Contact, Polymethylmethacrylate, Diagnostic   More FDA Info for this Device
510(K) Number	K012096
Device Name	Lens, Contact, Polymethylmethacrylate, Diagnostic
Applicant	OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. BELLEVUE, WA 98004-3039 US Other 510(k) Applications for this Company
Contact	RAYMOND GRAHAM Other 510(k) Applications for this Contact
Regulation Number	886.1385   More FDA Info for this Regulation Number
Classification Product Code	HJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2001
Decision Date	08/24/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review