FDA 510(k) Application Details - K980197

Device Classification Name	Lens, Contact (Other Material) - Daily   More FDA Info for this Device
510(K) Number	K980197
Device Name	Lens, Contact (Other Material) - Daily
Applicant	SPECIALTY ULTRAVISION, INC. 307 ORCHARD CITY DR. SUITE 100 CAMPBELL, CA 95008 US Other 510(k) Applications for this Company
Contact	IVALEE I COHEN Other 510(k) Applications for this Contact
Regulation Number	886.5916   More FDA Info for this Regulation Number
Classification Product Code	HQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/1998
Decision Date	08/04/1998
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