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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 K171150
Device Name AW-100
Applicant
Micron Corporation
2-17-7 Ikegami
Ota-Ku, Tokyo,  JP 146-0082
Applicant Contact Takashi Terui
Correspondent
Micron Corporation
2-17-7 Ikegami
Ota-Ku, Tokyo,  JP 146-0082
Correspondent Contact Takashi Terui
Regulation Number872.4850
Classification Product Code
ELC  
Date Received04/19/2017
Decision Date 03/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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