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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 K844250
Device Name OSADA ENAC
Applicant
Osada Electric Co., Ltd.
8242 W. 3rd St., Suite 150
Los Angeles,  CA  90048
Applicant Contact CHARLENE HARA
Correspondent
Osada Electric Co., Ltd.
8242 W. 3rd St., Suite 150
Los Angeles,  CA  90048
Correspondent Contact CHARLENE HARA
Regulation Number872.4850
Classification Product Code
ELC  
Date Received11/02/1984
Decision Date 01/23/1985
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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