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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 K093009
Device Name MACH LED SC
Applicant
DR. MACH GMBH & CO. KG
FLOSSMANNSTRABE 28
EBERSBERG,  DE 85560
Applicant Contact RAINER ADAMS
Correspondent
DR. MACH GMBH & CO. KG
FLOSSMANNSTRABE 28
EBERSBERG,  DE 85560
Correspondent Contact RAINER ADAMS
Regulation Number878.4580
Classification Product Code
FSY  
Date Received09/29/2009
Decision Date 04/01/2010
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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