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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 K120460
Device Name SMARTLUX
Applicant
MEDMIX CO., LTD
300 atwood
pittsburgh,  PA  15213
Contact peter chung
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/15/2012
Decision Date 10/01/2012
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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