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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 K140460
Device Name MACH LED 2SC
Applicant
DR. MACH GMBH & CO. KG
FEHMARNSTRASSE 31
NORDERSTEDT, SCHLESWIG-HOLSTEIN,  DE 22846
Applicant Contact GUDRUN BUSCH, PH.D.
Correspondent
DR. MACH GMBH & CO. KG
FEHMARNSTRASSE 31
NORDERSTEDT, SCHLESWIG-HOLSTEIN,  DE 22846
Correspondent Contact GUDRUN BUSCH, PH.D.
Regulation Number878.4580
Classification Product Code
FSY  
Date Received02/24/2014
Decision Date 04/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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