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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 K062731
Device Name ULTRASONIC SCALER, VARIOS 560
Applicant
Nakanishi, Inc.
700 Shimohinata
Kanuma-Shi,  JP 322-8666
Applicant Contact NORIMASA KANEKO
Correspondent
Nakanishi, Inc.
700 Shimohinata
Kanuma-Shi,  JP 322-8666
Correspondent Contact NORIMASA KANEKO
Regulation Number872.4850
Classification Product Code
ELC  
Date Received09/13/2006
Decision Date 05/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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