FDA 510(k) Application Details - K081681

Device Classification Name	Vitrectomy, Instrument Cutter   More FDA Info for this Device
510(K) Number	K081681
Device Name	Vitrectomy, Instrument Cutter
Applicant	ADVANCED MEDICAL OPTICS, INC. 1700 E. ST. ANDREW PLACE P.O. BOX 25162 SANTA ANA, CA 92705-4933 US Other 510(k) Applications for this Company
Contact	Evelyn De La Vega Other 510(k) Applications for this Contact
Regulation Number	886.4150   More FDA Info for this Regulation Number
Classification Product Code	MLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2008
Decision Date	10/08/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review