FDA 510(k) Application Details - K161012

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K161012
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	Bausch and Lomb, Inc. 50 Technology Drive Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Joyce Zhong 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	04/11/2016
Decision Date	07/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review