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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K142751
Device Name Chang Gung ComMed Series Dental Implant System
Applicant
Chang Gung Medical Technology Co., Ltd.
11f., # 201-4, Dunhua N. Rd. Songshan Dist
Taipei City,  TW 10508
Applicant Contact Chao-Chun Chiu
Correspondent
Chang Gung Medical Technology Co., Ltd.
11f., # 201-4, Dunhua N. Rd. Songshan Dist
Taipei City,  TW 10508
Correspondent Contact Chao-Chun Chiu
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/24/2014
Decision Date 06/15/2015
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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