FDA 510(k) Applications for Medical Device Product Code: KYB (Lens, Guide, Intraocular)

FDA 510(k) Applications for Medical Device Product Code "KYB"
(Lens, Guide, Intraocular)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K965185	ALCON LABORATORIES	ACRYPAK FOLDER	03/31/1997
K970033	ALCON LABORATORIES	MONARCH IOL DELIVERY SYSTEM	04/23/1997
K981571	ALCON LABORATORIES	MONARCH IOL DELIVERY SYSTEM	07/09/1998
K063155	ALCON MANUFACTURING, LTD.	MONARCH III IOL DELIVERY SYSTEM	03/27/2007
K001157	ALCON RESEARCH, LTD.	MONARCH II IOL DELIVERY SYSTEM	06/27/2000
K961242	ALLERGAN, INC.	AMO PHACOFLEX II INTERSECTION SYSTEM	06/17/1996
K063694	BAUSCH & LOMB, INC.	AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28	03/07/2007
K072985	DUCKWORTH & KENT, LTD.	DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2	06/20/2008
K081382	DUCKWORTH & KENT, LTD.	DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786	10/23/2008
K022723	MASTEL PRECISION, INC.	MASTEL 1 FOLDER IMPLANTATION SYSTEM	12/26/2002
K070669	MEDICEL AG	IOL INJECTOR SET	11/01/2007
K983129	STAAR SURGICAL CO.	DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)	12/04/1998
K032412	STAAR SURGICAL CO.	RE-USEABLE MICROSTAAR INJECTOR, MSI-S	06/10/2004
K152357	STAAR Surgical Company	MicroSTAAR Injector System Cartridges	10/30/2015