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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 K992504
Device Name EMS KERMIT
Applicant
(Ems Sa) Electro Medical Systems
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA J.M. NOLTE
Correspondent
(Ems Sa) Electro Medical Systems
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA J.M. NOLTE
Regulation Number872.4850
Classification Product Code
ELC  
Date Received07/27/1999
Decision Date 01/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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