FDA 510(k) Application Details - K053191

Device Classification Name	Lens, Contact, (Disposable)   More FDA Info for this Device
510(K) Number	K053191
Device Name	Lens, Contact, (Disposable)
Applicant	INNOVA VISION INC. 2904 N. BOLDT DRIVE FLAGGSTAFF, AZ 86001 US Other 510(k) Applications for this Company
Contact	JENNIFER REICH 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	11/15/2005
Decision Date	05/12/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review