FDA 510(k) Application Details - K082871

Device Classification Name	Folders And Injectors, Intraocular Lens (Iol)   More FDA Info for this Device
510(K) Number	K082871
Device Name	Folders And Injectors, Intraocular Lens (Iol)
Applicant	SIS LTD. SURGICAL INSTRUMENT SYSTEMS 5401 COTTONWOOD CT. GREENWOOD VILLAGE, CO 80121 US Other 510(k) Applications for this Company
Contact	Kevin Walls 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	09/29/2008
Decision Date	07/09/2009
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