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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Rotary Bone Cutting
510(k) Number K171155
Device Name Surgical Angle Handpiece, Surgical Straight Handpiece
Applicant
Nakanishi, Inc.
700 Shimonhinata
Kanuma-Shi,  JP 322-8666
Applicant Contact Kimihiko Satoh
Correspondent
Ken Block Consulting
1201 Richardson Dr.
Richardson,  TX  75080
Correspondent Contact Belia Juarez
Regulation Number872.4120
Classification Product Code
KMW  
Subsequent Product Code
EGS  
Date Received04/20/2017
Decision Date 11/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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