FDA 510(k) Application Details - K111882

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K111882
Device Name	Unit, Phacofragmentation
Applicant	ABBOTT MEDICAL OPTICS INC 1700 EAST SAINT ANDREW PL SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	ROSANNE M YETEMIAN Other 510(k) Applications for this Contact
Regulation Number	886.4670   More FDA Info for this Regulation Number
Classification Product Code	HQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2011
Decision Date	11/07/2011
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