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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
2, park pavilions, clos llyn
cwm, enterprise park
swansea,  GB sa6 8qy
Original Contact darren thomas
Regulation Number878.4810
Classification Product Code
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