FDA 510(k) Application Details - K113852

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K113852
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	BAUSCH & LOMB, INC. 30 ENTERPRISE SUITE 450 ALISO VIEJO, CA 92656 US Other 510(k) Applications for this Company
Contact	JASON SMITH 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	12/29/2011
Decision Date	09/28/2012
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