FDA 510(k) Application Details - K121721

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K121721
Device Name	Unit, Phacofragmentation
Applicant	ABBOTT MEDICAL OPTICS INC 1700 E. ST. ANDREW PLACE SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	ABBAS M BOHRA 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	06/12/2012
Decision Date	10/15/2012
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