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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, floor standing
510(k) Number K970886
Device Name HANAULUX BLUE 80 HOSPITAL
Applicant
HERAEUS MED GMBH
HERAEUSSTRASSE 12-14
HANAU,  DE D-63450
Applicant Contact MARK SCHULZ
Correspondent
HERAEUS MED GMBH
HERAEUSSTRASSE 12-14
HANAU,  DE D-63450
Correspondent Contact MARK SCHULZ
Regulation Number878.4580
Classification Product Code
FSS  
Date Received02/06/1997
Decision Date 04/16/1997
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
Recalls CDRH Recalls
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