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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, accessories
510(k) Number K133554
Device Name SURGICAL LIGHT HANDLE COVER
Applicant
MICROTEK MEDICAL, INC. AN ECOLAB COMPANY
370 WABASHA STREET N
ST. PAUL,  MN  55102
Applicant Contact ANDY ROLLER
Correspondent
MICROTEK MEDICAL, INC. AN ECOLAB COMPANY
370 WABASHA STREET N
ST. PAUL,  MN  55102
Correspondent Contact ANDY ROLLER
Regulation Number878.4580
Classification Product Code
FTA  
Date Received11/19/2013
Decision Date 04/08/2014
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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