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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 K954169
Device Name HANAULUX BLUE 30 & 80
Applicant
HERAEUS MED GMBH
HERAEUSSTRASSE 12-14
HANAU,  DE D-63450
Applicant Contact MARKUS STECKHAN
Correspondent
HERAEUS MED GMBH
HERAEUSSTRASSE 12-14
HANAU,  DE D-63450
Correspondent Contact MARKUS STECKHAN
Regulation Number878.4580
Classification Product Code
FSY  
Subsequent Product Code
FSS  
Date Received09/05/1995
Decision Date 02/01/1996
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
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