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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 K093000
Device Name EMS PIEZON MASTER 700
Applicant
E.M.S Electro Medical Systems S.A
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA J.M NOLTE
Correspondent
E.M.S Electro Medical Systems S.A
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA J.M NOLTE
Regulation Number872.4850
Classification Product Code
ELC  
Date Received09/28/2009
Decision Date 07/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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