FDA 510(k) Application Details - K112977

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K112977
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY FORT WORTH, TX 76134-2099 US Other 510(k) Applications for this Company
Contact	Catherine Goble 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	10/06/2011
Decision Date	03/27/2012
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