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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
Model X X Y-N-S-W, X=NUMBER OF LIGHT PODS, Y= NUMBER OF LED, N= PHYSICAL CONFIGURATIONS, S= VARIATION, W= CUSTOM VARIATIONS
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
Original Applicant
HUOT INSTRUMENTS, LLC
n50 w13740 overview dr.
suite a
menomonee falls,  WI  53051
Original 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 (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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