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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K980162
Device Name MACH-SIGMA HANDPIECE, ULTRAPUSH
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
EFB  
Date Received01/16/1998
Decision Date 06/05/1998
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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