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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 K900709
Device Name AIR FLOW SII
Applicant
Electro Medical Systems (Ems Sa)
Rte De Champ-Colin 2
Nyon,  CH CH-1260
Applicant Contact MAURICE PICHE
Correspondent
Electro Medical Systems (Ems Sa)
Rte De Champ-Colin 2
Nyon,  CH CH-1260
Correspondent Contact MAURICE PICHE
Regulation Number872.4850
Classification Product Code
ELC  
Date Received11/30/1989
Decision Date 04/18/1990
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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