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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 K150798
Device Name Codent Low Speed Dental Handpieces and Accessories
Applicant
CODENT TECHNICAL INDUSTRY CO., LTD.
5F., No.90, Luke 5th Rd., Luzhu District
SOUTHERN TAIWAN SCIENCE PARK
Kaohsiung City,  TW 82151
Applicant Contact Chin-Ting Wen
Correspondent
CODENT TECHNICAL INDUSTRY CO., LTD.
5F., No.90, Luke 5th Rd., Luzhu District
SOUTHERN TAIWAN SCIENCE PARK
Kaohsiung City,  TW 82151
Correspondent Contact Chin-Ting Wen
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EGS  
Date Received03/26/2015
Decision Date 04/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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