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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 K991874
Device Name EMS SURFACE MOUNT SCALER
Applicant
(EMS SA) ELECTRO MEDICAL SYSTEMS
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
(EMS SA) ELECTRO MEDICAL SYSTEMS
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number872.4850
Classification Product Code
ELC  
Date Received06/02/1999
Decision Date 07/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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