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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Led Light Source
510(k) Number K113679
Device Name LUCEA LED SURGICAL LIGHT SYSTEM
Applicant
Maquet S.A.S.
45 Barbour Pond Dr.
Wayne,  NJ  07470
Applicant Contact WHITNEY TORNING
Correspondent
Maquet S.A.S.
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact WHITNEY TORNING
Regulation Number876.1500
Classification Product Code
NTN  
Subsequent Product Codes
FSS   FTD  
Date Received12/14/2011
Decision Date 01/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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