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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 K024132
Device Name CHROMOPHARE X 65
Applicant
BERCHTOLD HOLDING GMBH
LUDWIGSTALER STR. 25
TUTTLINGEN,  DE D-78532
Applicant Contact JORG SCHNEIDER
Correspondent
BERCHTOLD HOLDING GMBH
LUDWIGSTALER STR. 25
TUTTLINGEN,  DE D-78532
Correspondent Contact JORG SCHNEIDER
Regulation Number878.4580
Classification Product Code
FSY  
Date Received12/16/2002
Decision Date 03/21/2003
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
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