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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, fiberoptic
510(k) Number K100395
Device Name HARMONY VLED SURGICAL LIGHTNING SYSTEM
Applicant
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Applicant Contact ROBERT SULLIVAN
Correspondent
STERIS Corporation
5960 Heisley Road
Mentor,  OH  44060
Correspondent Contact ROBERT SULLIVAN
Regulation Number878.4580
Classification Product Code
FST  
Date Received02/16/2010
Decision Date 03/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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