FDA 510(k) Application Details - K002589

Device Classification Name	Accessories, Soft Lens Products   More FDA Info for this Device
510(K) Number	K002589
Device Name	Accessories, Soft Lens Products
Applicant	ALCON UNIVERSAL, LTD. 6201 SOUTH FREEWAY FORT WORTH, TX 76134-2099 US Other 510(k) Applications for this Company
Contact	MICHAEL E PFLEGER Other 510(k) Applications for this Contact
Regulation Number	886.5928   More FDA Info for this Regulation Number
Classification Product Code	LPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2000
Decision Date	10/23/2000
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