FDA 510(k) Application Details - K051430

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K051430
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	HYDROGEL VISION CORPORATION 7575 COMMERCE COURT SARASOTA, FL 34243 US Other 510(k) Applications for this Company
Contact	DONNA HOVANEC 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	06/01/2005
Decision Date	07/18/2005
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