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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 K071561
Device Name HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D
Applicant
Beijing North Pole Dental Handpiece Co., Ltd.
Suite 8d, No, 19 Lane 999,
Zhongshan No, 2 Rd.(S)
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Beijing North Pole Dental Handpiece Co., Ltd.
Suite 8d, No, 19 Lane 999,
Zhongshan No, 2 Rd.(S)
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number872.4200
Classification Product Code
EFB  
Date Received06/07/2007
Decision Date 10/12/2007
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
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