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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 K080857
Device Name CHROMOPHARE E-SERIES
Applicant
Berchtold Holding GmbH
Ludwigstaler Strabe 25
Tuttlingen,  DE D-78532
Applicant Contact SILKE GORAL
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number878.4580
Classification Product Code
FSY  
Date Received03/27/2008
Decision Date 04/10/2008
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
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