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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 K030603
Device Name PROANGLE DISPOSABLE PROPHY ANGLE
Applicant
Pac-Dent International (Suzhou), Ltd.
125 Binhe Rd.
New District Of Suzhou City
Jiangsu Province,  CN 215011
Applicant Contact XU WANG
Correspondent
Pac-Dent International (Suzhou), Ltd.
125 Binhe Rd.
New District Of Suzhou City
Jiangsu Province,  CN 215011
Correspondent Contact XU WANG
Regulation Number872.4200
Classification Product Code
EGS  
Date Received02/25/2003
Decision Date 04/14/2003
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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