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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Ceiling Mounted
510(k) Number K060802
Device Name VISUM LED SURGICAL LIGHTING SYSTEM
Applicant
Stryker Communications Corp.
1410 Lakeside Pkwy. #100
Flower Mound,  TX  75028
Applicant Contact LOUIS-PIERRE MARCOUX
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number878.4580
Classification Product Code
FSY  
Date Received03/24/2006
Decision Date 04/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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