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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 K873146
Device Name USI BASIC. AG 1050. AG 1090
Applicant
Cranston Ind., Inc.
P.O. Box 441
Baldwin City,  KS  66006
Applicant Contact DALE O CRANSTON
Correspondent
Cranston Ind., Inc.
P.O. Box 441
Baldwin City,  KS  66006
Correspondent Contact DALE O CRANSTON
Regulation Number872.4850
Classification Product Code
ELC  
Date Received08/11/1987
Decision Date 10/27/1987
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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