FDA 510(k) Application Details - K003826

Device Classification Name	Lens, Contact, (Disposable)   More FDA Info for this Device
510(K) Number	K003826
Device Name	Lens, Contact, (Disposable)
Applicant	CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. DULUTH, GA 30097 US Other 510(k) Applications for this Company
Contact	ALICIA M PLESNARSKI Other 510(k) Applications for this Contact
Regulation Number	886.5925   More FDA Info for this Regulation Number
Classification Product Code	MVN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2000
Decision Date	03/08/2001
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