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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 K990656
Device Name CHROMOPHARE D 530 LDR SURGICAL LIGHT
Applicant
BERCHTOLD HOLDING GMBH
LUDWIGSTALER STR. 25
TUTTLINGEN,  DE D-78532
Applicant Contact WOLFRAM K HILL
Correspondent
BERCHTOLD HOLDING GMBH
LUDWIGSTALER STR. 25
TUTTLINGEN,  DE D-78532
Correspondent Contact WOLFRAM K HILL
Regulation Number878.4580
Classification Product Code
FSY  
Date Received03/01/1999
Decision Date 07/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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