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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 K120377
Device Name ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
Original Applicant
J. MORITA USA, INC.
1425 k street nw
suite 1100
washington,  DC  20005
Original Contact keith a barritt
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/06/2012
Decision Date 07/25/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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