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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 EAST AURORA ROAD
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
Recalls CDRH Recalls
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