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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, TOCHIGI-KEN,  JP 322-8666
Applicant Contact NORIMASA KANEKO
Correspondent
NAKANISHI, INC.
700 SHIMOHINATA
KANUMA-SHI, TOCHIGI-KEN,  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
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