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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Folders And Injectors, Intraocular Lens (Iol)
510(k) Number K082871
Device Name XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
Applicant
Sis Ltd., Surgical Instrument Systems
5401 Cottonwood Ct.
Greenwood Village,  CO  80121
Applicant Contact Kevin Walls
Correspondent
Sis Ltd., Surgical Instrument Systems
5401 Cottonwood Ct.
Greenwood Village,  CO  80121
Correspondent Contact Kevin Walls
Regulation Number886.4300
Classification Product Code
MSS  
Date Received09/29/2008
Decision Date 07/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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