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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 K071447
Device Name VARIOS 75
Applicant
NAKANISHI, INC.
700 SHIMOHINATA
KANUMA-SHI, TOCHIGI-KEN,  JP 322-8666
Applicant Contact TOMOKO HIRABAYASHI
Correspondent
NAKANISHI, INC.
700 SHIMOHINATA
KANUMA-SHI, TOCHIGI-KEN,  JP 322-8666
Correspondent Contact TOMOKO HIRABAYASHI
Regulation Number872.4850
Classification Product Code
ELC  
Date Received05/24/2007
Decision Date 04/18/2008
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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