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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 K944855
Device Name CHROMOPHARE
Applicant
Berchtold Holding GmbH
Postfach 4052
Tuttlingen,  DE D-78505
Applicant Contact W HILL
Correspondent
Berchtold Holding GmbH
Postfach 4052
Tuttlingen,  DE D-78505
Correspondent Contact W HILL
Regulation Number878.4580
Classification Product Code
FSY  
Subsequent Product Code
FSS  
Date Received09/30/1994
Decision Date 10/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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