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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 K922836
Device Name CHROMOPHARE
Applicant
BERCHTOLD HOLDING GMBH
LUDWIGSTALER STR. 25
TUTTLINGEN,  DE D-78532
Applicant Contact DAVID N BULMAN
Correspondent
BERCHTOLD HOLDING GMBH
LUDWIGSTALER STR. 25
TUTTLINGEN,  DE D-78532
Correspondent Contact DAVID N BULMAN
Regulation Number878.4580
Classification Product Code
FSY  
Date Received06/12/1992
Decision Date 10/09/1992
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
Recalls CDRH Recalls
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