FDA 510(k) Application Details - K143434

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K143434
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	ABBOTT MEDICAL OPTICS INC 1700 EAST SAINT ANDREW PL SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	Nooshin Azizi 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	12/01/2014
Decision Date	05/06/2015
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