FDA 510(k) Application Details - K081443

Device Classification Name	Lens, Contact (Other Material) - Daily   More FDA Info for this Device
510(K) Number	K081443
Device Name	Lens, Contact (Other Material) - Daily
Applicant	MENICON CO. LTD. 269A BALLARDVALE ST. WILMINGTON, MA 01887 US Other 510(k) Applications for this Company
Contact	BEVERLEY D VENUTI 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	05/22/2008
Decision Date	09/23/2008
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