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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 K903298
Device Name DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP
Applicant
Micro Motors, Inc.
151 E. Columbine Ave.
Santa Ana,  CA  92707
Applicant Contact RUSS REINSCH
Correspondent
Micro Motors, Inc.
151 E. Columbine Ave.
Santa Ana,  CA  92707
Correspondent Contact RUSS REINSCH
Regulation Number872.4850
Classification Product Code
ELC  
Date Received07/24/1990
Decision Date 04/16/1991
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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