FDA 510(k) Application Details - K123994

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K123994
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, PH.D., RAC 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	12/26/2012
Decision Date	02/21/2013
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