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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 K120392
Device Name CHROMOPHARE F 628 AND F 528
Applicant
BERCHTOLD GMBH & CO. KG
LUDWIGSTALER STR. 25
TUTTLINGEN,  DE D-78532
Applicant Contact VOLKER HORNSCHEIDT
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number878.4580
Classification Product Code
FSY  
Date Received02/08/2012
Decision Date 02/16/2012
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
Recalls CDRH Recalls
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