FDA 510(k) Application Details - K081545

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K081545
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	ADVANCED MEDICAL OPTICS, INC. 1700 EAST ST. ANDREW PL. SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	KIM REGIS Other 510(k) Applications for this Contact
Regulation Number	886.4300   More FDA Info for this Regulation Number
Classification Product Code	MSS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2008
Decision Date	10/02/2008
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