FDA 510(k) Application Details - K083216

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K083216
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY DULUTH, GA 30097 US Other 510(k) Applications for this Company
Contact	MARTINA HEIM Other 510(k) Applications for this Contact
Regulation Number	886.5925   More FDA Info for this Regulation Number
Classification Product Code	LPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2008
Decision Date	04/14/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review