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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 K972924
Device Name SURGIC II IMPLANT CONTROL UNIT
Applicant
Nsk Nakanishi, Inc.
340 Kamihinata, Kanuma-Shi
Tochigi-Ken,  JP 322
Applicant Contact HIROJI SEKIGUCHI
Correspondent
Nsk Nakanishi, Inc.
340 Kamihinata, Kanuma-Shi
Tochigi-Ken,  JP 322
Correspondent Contact HIROJI SEKIGUCHI
Regulation Number872.4200
Classification Product Code
EBW  
Date Received08/08/1997
Decision Date 10/30/1997
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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