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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K020327
Device Name SURGIC IV IMPLANT CONTROL UNIT
Applicant
Nakanishi, Inc.
700 Shimohinata
Kanuma-Shi,  JP 322-8666
Applicant Contact HIROJI SEKIGUCHI
Correspondent
Nakanishi, Inc.
700 Shimohinata
Kanuma-Shi,  JP 322-8666
Correspondent Contact HIROJI SEKIGUCHI
Regulation Number872.4200
Classification Product Code
EBW  
Date Received01/31/2002
Decision Date 04/08/2002
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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