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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 K991527
Device Name CHROMOPHARE D500, D530, D650
Applicant
Berchtold Holding GmbH
Ludwigstaler St. 25
Tuttlingen,  DE D-78532
Applicant Contact WOLFRAM K HILL
Correspondent
Berchtold Holding GmbH
Ludwigstaler St. 25
Tuttlingen,  DE D-78532
Correspondent Contact WOLFRAM K HILL
Regulation Number878.4580
Classification Product Code
FSY  
Date Received05/03/1999
Decision Date 05/27/1999
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
Predetermined Change
Control Plan Authorized		 No
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