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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 K973466
Device Name HANAULUX BLUE 75 AND HANAULUX BLUE 120
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
FSY  
Date Received08/15/1997
Decision Date 10/24/1997
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
Predetermined Change
Control Plan Authorized		 No
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