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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 K120573
Device Name MEDART 620
Original Applicant
MEDART A/S
2, park pavilions, clos llyn
cwm, enterprise park
swansea,  GB sa6 8qy
Original Contact darren thomas
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/27/2012
Decision Date 06/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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