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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 K031421
Device Name ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
Applicant
Nakanishi, Inc.
700b Cooper Ct.
Schaumburg,  IL  60173
Applicant Contact MASAYUKI ONOGUCHI
Correspondent
Nakanishi, Inc.
700b Cooper Ct.
Schaumburg,  IL  60173
Correspondent Contact MASAYUKI ONOGUCHI
Regulation Number872.4850
Classification Product Code
ELC  
Date Received05/05/2003
Decision Date 03/26/2004
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
Recalls CDRH Recalls
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