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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K972569
Device Name E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
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
EGS  
Date Received07/10/1997
Decision Date 10/08/1997
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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