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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 K100702
Device Name STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS
Applicant
Huot Instruments, LLC
N50 W13740 Overview Dr.
Suite A
Menomonee Falls,  WI  53051
Applicant Contact ANNE WARD
Correspondent
Huot Instruments, LLC
N50 W13740 Overview Dr.
Suite A
Menomonee Falls,  WI  53051
Correspondent Contact ANNE WARD
Regulation Number878.4580
Classification Product Code
FSY  
Subsequent Product Codes
FSS   FTD  
Date Received03/12/2010
Decision Date 07/20/2010
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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