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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 K102758
Device Name TRULIGHT 5520 AND TRULIGHT 5320
Applicant
Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
1046 Legrand Blvd.
Charleston,  SC  29492
Applicant Contact LINDSEY RONNENBERG
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number878.4580
Classification Product Code
FSY  
Subsequent Product Codes
FQP   FSQ   FTD  
Date Received09/23/2010
Decision Date 10/26/2010
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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