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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 St. N.
Saint Paul,  MN  55102
Applicant Contact ANDY ROLLER
Correspondent
Microtek Medical, Inc. an Ecolab Company
370 Wabasha St. N.
Saint 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
Predetermined Change
Control Plan Authorized		 No
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