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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) Number K082033
Device Name NANNOLIGHT INTENSE PULSED LIGHT SYSTEM
Original Applicant
GLOBAL USA DISTRIBUTION, LLC.
10723 aquila av. s.
minneapolis,  MN  55438
Original Contact matt makousky
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/17/2008
Decision Date 07/31/2008
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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