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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Surgical
510(k) Number K932451
Device Name HANAULUX 2005 SURGICAL LIGHT
Applicant
Heraeus Instruments GmbH
Heraeus Strasse 12-14
Hanau,  DE 63450
Applicant Contact MARKUS STECKHAN
Correspondent
Heraeus Instruments GmbH
Heraeus Strasse 12-14
Hanau,  DE 63450
Correspondent Contact MARKUS STECKHAN
Regulation Number878.4580
Classification Product Code
FTD  
Date Received05/20/1993
Decision Date 11/12/1993
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
Recalls CDRH Recalls
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