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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 K120932
Device Name OPELASER PRO II AND THE OPELASER LITE II
Original Applicant
THE YOSHIDA DENTAL MFG. CO., LTD.
8870 racello ct
naples,  FL  34114
Original Contact daniel kamm
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/28/2012
Decision Date 12/07/2012
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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