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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 K895715
Device Name HANAULUX(R) 2000
Applicant
W.C. Heraeus GmbH
Postfach 1553
D-6450 Hanau 1
West Germany,  DE
Applicant Contact KLAAS OOSTLANDER
Correspondent
W.C. Heraeus GmbH
Postfach 1553
D-6450 Hanau 1
West Germany,  DE
Correspondent Contact KLAAS OOSTLANDER
Regulation Number878.4580
Classification Product Code
FTD  
Date Received09/25/1989
Decision Date 10/13/1989
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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