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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 K953026
Device Name MINIPIEZON
Applicant
Electro Medical Systems SA
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact STEVEN CLARKE
Correspondent
Electro Medical Systems SA
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact STEVEN CLARKE
Regulation Number872.4850
Classification Product Code
ELC  
Date Received06/29/1995
Decision Date 08/28/1995
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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