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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K132445
Device Name PIEZON 250
Applicant
E.M.S Electro Medical Systems S.A
62 Forest St., Suite 300
Marlborough,  MA  01752
Applicant Contact CYNTHIA NOLTE
Correspondent
E.M.S Electro Medical Systems S.A
62 Forest St., Suite 300
Marlborough,  MA  01752
Correspondent Contact CYNTHIA NOLTE
Regulation Number872.4850
Classification Product Code
ELC  
Date Received08/06/2013
Decision Date 12/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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